Latest news with #CGRP
Associated Press
4 days ago
- Health
- Associated Press
AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention
NORTH CHICAGO, Ill., June 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1 The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).1 The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).1 'These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine,' said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. 'This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease.' Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.2 It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide.2 Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.3 'Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options,' said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. 'The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention.' The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.1 Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in adults. Full results from the TEMPLE study will be presented at an upcoming medical meeting. About the TEMPLE Study TEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada. The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests. The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes. More information on the TEMPLE trial can be found on (NCT05748483). About Atogepant Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. U.S. Uses and Important Safety Information What is QULIPTA® (atogepant)? QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION FOR QULIPTA® Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines. QULIPTA can cause serious side effects, including: The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Migraine At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives. In the United States, AbbVie is the only company with three prescription treatments designed to meet patient needs across the spectrum of migraine to help patients living with this debilitating disease. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn,Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ALL-NEUR-250043 Contact(s): Global Media: Amber Landis +1 (231) 557-6596 [email protected] U.S. Media: Sara Sanders +1 (973) 307-6145 [email protected] References View original content: SOURCE AbbVie
Yahoo
4 days ago
- Health
- Yahoo
AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention
TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month1 Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy1 Full results from the TEMPLE study will be presented at an upcoming medical meeting NORTH CHICAGO, Ill., June 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1 The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).1 The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).1 "These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease." Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.2 It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide.2 Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.3 "Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention." The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.1 Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in results from the TEMPLE study will be presented at an upcoming medical meeting. About the TEMPLE StudyTEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada. The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests. The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes. More information on the TEMPLE trial can be found on (NCT05748483). About Atogepant Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. U.S. Uses and Important Safety Information What is QULIPTA® (atogepant)? QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION FOR QULIPTA®Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you: Have high blood pressure Have circulation problems in your fingers and toes Have kidney problems or are on dialysis Have liver problems Are pregnant or plan to become pregnant Are breastfeeding or plan to breastfeed Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines. QULIPTA can cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash. High blood pressure: New or worsening of high blood pressure can happen. Contact your healthcare provider if you have an increase in blood pressure. Raynaud's phenomenon: A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur. The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in MigraineAt AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives. In the United States, AbbVie is the only company with three prescription treatments designed to meet patient needs across the spectrum of migraine to help patients living with this debilitating disease. About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ALL-NEUR-250043 Contact(s): Global Media:Amber Landis+1 (231) U.S. Media:Sara Sanders+1 (973) References Data on file. AbbVie, Inc. ABVRRTI81148 Steiner TJ, Stovner LJ, Jensen R, et al. Migraine remains second among the world's causes of disability, and first among young women: Findings from GBD2019. The Journal of Headache and Pain.2020;21(1):137. Buse DC, Sakai F, Matharu M, Reed ML, Fanning K, Dabruzzo B, Lipton RB. Characterizing gaps in the preventive pharmacologic treatment of migraine: Multi-country results from the CaMEO-I study. Headache. 2024;64(5):469-481. View original content: SOURCE AbbVie Sign in to access your portfolio
Medscape
12-06-2025
- Health
- Medscape
Migraine Expert Renews Call for Prompt, Effective Management
OTTAWA — Therapies that target calcitonin gene-related peptide (CGRP) should be used up front in the treatment and prevention of migraine because of their efficacy, safety, and potential to modify the disease course, an expert said. Speaking at the annual meeting of the Canadian Neurological Sciences Federation (CNSF) Congress 2025, David Dodick, MD, emeritus professor of neurology at Mayo Clinic in Phoenix, reiterated the appeal that was first published in an American Headache Society position statement: That migraine therapies that target CGRP become first-line treatments for migraine. A Bold Call Some of the available monoclonal antibodies to treat migraine include erenumab, fremanezumab, galcanezumab, and eptinezumab. The class of 'gepants' includes rimegepant and atogepant. All these treatments target CGRP. 'This was a type of expert consensus opinion,' Dodick told Medscape Medical News , referring to the 'rather bold' position statement. 'The real-world evidence supports what we saw in clinical trials, and we now know the safety profile of these [therapies] because we've had them for almost 8 years of use in clinical practice. They are not first-line [therapies] simply because of cost.' The largest prospective study on the use of anti-CGRP monoclonal antibodies demonstrated robust responses to these therapies. Because CGRP-targeting therapies are well tolerated, discontinuation due to adverse events is generally not a concern, and increased efficacy may be realized if patients stay the course with CGRP-targeting therapies, said Dodick. 'You can imagine that if people are able to tolerate them and stay on these drugs longer, then efficacy is cumulative over time. Adherence and compliance increase the response rate over time,' said Dodick. Early Treatment Vital 'It really does matter how early you get to the patient and treat them effectively, both from the standpoint of treating an individual episode of migraine and from the prevention standpoint: That is, treating the disease earlier,' said Dodick. 'The more frequent that migraines are, and the more you allow them to be frequent, the more likely they are to progress to a daily migraine, and the more difficult they are to manage.' In the US and Canada, patients with migraine must first fail other treatments before they are prescribed newer agents like CGRP monoclonal antibodies or gepants, and this requirement creates the potential for a lapse in care, noted Dodick. 'Patients can become discouraged and lost to follow-up if they fail one medicine and then two medicines,' which he said supports the case for first-line access to CGRP-targeting migraine therapies. High-Impact Agents The efficacy of migraine treatments that target CGRP is convincing, said Michael Hill, MD, professor of clinical neuroscience at the University of Calgary's Cumming School of Medicine, Calgary. 'For some patients, they can get back to living a relatively normal life,' said Hill, who also is CNSF president. 'It can be a remarkable evolution. They go from being nonfunctioning and not working to being fully functional again because their migraine is not chronic, or their recurrent migraines are not so disabling.' Seeing patients who are unable to access these therapies is disheartening, Hill told Medscape Medical News. 'It is hard to see them denied this therapy.' The preventive potential that these therapies could offer would certainly be welcome, Hill added. 'The idea that some of these people who start with simple migraine and progress to a chronic, refractory migraine state, and that these might actually be preventable with early treatment, is really exciting.' Episodic treatment of migraine has not altered the disease course. 'The focus on migraine therapy has been on acute treatment and not so much on this idea that you might prevent the evolving chronicity of the disease.'
Malaysian Reserve
21-05-2025
- Health
- Malaysian Reserve
Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval
The approval of ATZUMI and BREKIYA is expected to significantly reshape the migraine market by introducing new, innovative treatment options. These therapies promise improved efficacy and convenience, potentially capturing a substantial share from existing CGRP inhibitors. Their entry may intensify competition, drive pricing adjustments, and stimulate further innovation. LAS VEGAS, May 21, 2025 /PRNewswire/ — Migraine is recognized globally as the seventh most disabling condition across all diseases, accounting for approximately 2.9% of all years lived with disability (YLDs). It is also the top cause of disability among neurological disorders. Despite its prevalence, migraine is often underdiagnosed and undertreated. Around 50% of sufferers go undiagnosed, and fewer than half seek medical consultation. In 2024, the estimated number of individuals living with migraine in the 7MM reached roughly 119 million. Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), and anti-nausea medications, which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers. Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (Botox), and topiramate. While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications. Learn more about the migraine therapeutic market @ Migraine Treatment Market Eptinezumab (ALD-403), marketed as VYEPTI, is approved for the preventive treatment of migraines in adults. Aimovig, developed by Amgen and Novartis, was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes. FDA approved EMGALITY in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019, the EU approved galcanezumab for adults with ≥4 migraine days/month. In September 2019, the FDA sanctioned AJOVY for adult migraine prevention. By January 2020, an autoinjector for Fremanezumab received FDA approval. In March 2019, AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021. In September 2021, Impel Pharmaceuticals gained FDA approval for TRUDHESA, a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults. In March 2023, Pfizer's ZAVZPRET (zavegepant) received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery. The FDA also approved QULIPTA (atogepant) in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, IntelGenx Corp announced FDA approval of RIZAFILM, designed for the acute treatment of migraines. Additionally, in January 2025, the FDA approved AXS-07, an oral multi-mechanistic treatment for acute migraine attacks, developed by Axsome Therapeutics. Branded as SYMBRAVO, it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024. Dive deep into the United States migraine drugs market @ Migraine Headache Drugs Market On April 30, 2025, the FDA approved ATZUMI, a nasal powder formulation of dihydroergotamine (DHE), developed by Satsuma Pharmaceuticals, for the acute treatment of migraines in adults. Satsuma is a subsidiary of Shin Nippon Biomedical Laboratories. ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form. The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested. The recent approval was supported by results from a Phase I pharmacokinetics study and the Phase III ASCEND trial. These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use. Recently, in May 2025, Amneal Pharmaceuticals, Inc. announced that the FDA had approved BREKIYA (dihydroergotamine mesylate) injection, the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025. The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened. To know more about the migraine treatment devices, visit @ Migraine Treatment Devices Market Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options. Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include ABP-450 (Axsome Therapeutics), Aimovig (AEON Biopharma, Inc.), Lu AG09222 (Lundbeck), and others. Discover which therapies are expected to grab major migraine therapeutics market share @ Migraine Drugs Market ABP-450, developed by AEON Biopharma, Inc., is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from Clostridium botulinum. At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine. Aimovig, produced by Amgen, is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms. Lu AG09222, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine. Discover more about migraine drugs in development @ Migraine Clinical Trials The anticipated launch of these emerging migraine treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the migraine market size in the 7MM is expected to grow from USD 10.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market. DelveInsight's latest published market report titled Migraine Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Migraine Gender-specific Prevalent Cases of Migraine Severity-specific Prevalent Cases of Migraine Diagnosed Cases of Episodic and Chronic Migraine The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this migraine market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space. Related Reports Migraine Epidemiology Forecast Migraine Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Migraine Pipeline Migraine Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cluster headache companies including Novartis AG, Zosano Pharma, Eli Lilly and Company, AstraZeneca Plc., Autonomic Technologies, Inc., ElectroCore Medical LLC., GlaxoSmithKline Plc, Winston Pharmaceuticals Inc., Lundback Seattle BioPharmaceutical, among others. Cluster Headache Pipeline Cluster Headache Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cluster headache companies, including Lundbeck, Eli Lilly, AstraZeneca, GlaxoSmithKline, Zosano Pharma, GlaxoSmithKline, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakurinfo@ +14699457679 Logo: View original content:
Yahoo
21-05-2025
- Health
- Yahoo
Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval
The approval of ATZUMI and BREKIYA is expected to significantly reshape the migraine market by introducing new, innovative treatment options. These therapies promise improved efficacy and convenience, potentially capturing a substantial share from existing CGRP inhibitors. Their entry may intensify competition, drive pricing adjustments, and stimulate further innovation. LAS VEGAS, May 21, 2025 /PRNewswire/ -- Migraine is recognized globally as the seventh most disabling condition across all diseases, accounting for approximately 2.9% of all years lived with disability (YLDs). It is also the top cause of disability among neurological disorders. Despite its prevalence, migraine is often underdiagnosed and undertreated. Around 50% of sufferers go undiagnosed, and fewer than half seek medical consultation. In 2024, the estimated number of individuals living with migraine in the 7MM reached roughly 119 million. Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), and anti-nausea medications, which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers. Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (Botox), and topiramate. While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications. Learn more about the migraine therapeutic market @ Migraine Treatment Market Eptinezumab (ALD-403), marketed as VYEPTI, is approved for the preventive treatment of migraines in adults. Aimovig, developed by Amgen and Novartis, was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes. FDA approved EMGALITY in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019, the EU approved galcanezumab for adults with ≥4 migraine days/month. In September 2019, the FDA sanctioned AJOVY for adult migraine prevention. By January 2020, an autoinjector for Fremanezumab received FDA approval. In March 2019, AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021. In September 2021, Impel Pharmaceuticals gained FDA approval for TRUDHESA, a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults. In March 2023, Pfizer's ZAVZPRET (zavegepant) received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery. The FDA also approved QULIPTA (atogepant) in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, IntelGenx Corp announced FDA approval of RIZAFILM, designed for the acute treatment of migraines. Additionally, in January 2025, the FDA approved AXS-07, an oral multi-mechanistic treatment for acute migraine attacks, developed by Axsome Therapeutics. Branded as SYMBRAVO, it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024. Dive deep into the United States migraine drugs market @ Migraine Headache Drugs Market On April 30, 2025, the FDA approved ATZUMI, a nasal powder formulation of dihydroergotamine (DHE), developed by Satsuma Pharmaceuticals, for the acute treatment of migraines in adults. Satsuma is a subsidiary of Shin Nippon Biomedical Laboratories. ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form. The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested. The recent approval was supported by results from a Phase I pharmacokinetics study and the Phase III ASCEND trial. These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use. Recently, in May 2025, Amneal Pharmaceuticals, Inc. announced that the FDA had approved BREKIYA (dihydroergotamine mesylate) injection, the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025. The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened. To know more about the migraine treatment devices, visit @ Migraine Treatment Devices Market Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options. Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include ABP-450 (Axsome Therapeutics), Aimovig (AEON Biopharma, Inc.), Lu AG09222 (Lundbeck), and others. Discover which therapies are expected to grab major migraine therapeutics market share @ Migraine Drugs Market ABP-450, developed by AEON Biopharma, Inc., is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from Clostridium botulinum. At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine. Aimovig, produced by Amgen, is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms. Lu AG09222, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine. Discover more about migraine drugs in development @ Migraine Clinical Trials The anticipated launch of these emerging migraine treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the migraine market size in the 7MM is expected to grow from USD 10.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market. DelveInsight's latest published market report titled Migraine Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Migraine Gender-specific Prevalent Cases of Migraine Severity-specific Prevalent Cases of Migraine Diagnosed Cases of Episodic and Chronic Migraine The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this migraine market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space. Related Reports Migraine Epidemiology Forecast Migraine Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Migraine Pipeline Migraine Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cluster headache companies including Novartis AG, Zosano Pharma, Eli Lilly and Company, AstraZeneca Plc., Autonomic Technologies, Inc., ElectroCore Medical LLC., GlaxoSmithKline Plc, Winston Pharmaceuticals Inc., Lundback Seattle BioPharmaceutical, among others. Cluster Headache Pipeline Cluster Headache Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cluster headache companies, including Lundbeck, Eli Lilly, AstraZeneca, GlaxoSmithKline, Zosano Pharma, GlaxoSmithKline, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakurinfo@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Sign in to access your portfolio
