Latest news with #eptinezumab
Yahoo
3 hours ago
- Health
- Yahoo
New data from phase III trial confirms efficacy of Vyepti® (eptinezumab) in Asian population with chronic migraine
The full results of the phase III registrational SUNRISE trial were presented at the European Academy of Neurology 2025 Annual Congress, where eptinezumab demonstrated statistically significant reductions in mean monthly migraine days (MMDs) compared with placebo1 Patients receiving eptinezumab were four times more likely to achieve a reduction of ≥75% in MMDs within the first 4 weeks, compared to placebo1 The SUNRISE trial met all key secondary efficacy endpoints with improvements seen as early as day 1 and sustained through week 121 VALBY, Denmark, June 21, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced the full results from the SUNRISE trial, a randomized, placebo-controlled trial designed to evaluate the efficacy and safety of eptinezumab versus placebo in a predominantly Asian population with chronic migraine. The study was presented at the 11th Congress of the European Academy of Neurology taking place in Helsinki 21-24 June.1 "Various treatments are recommended for patients with migraine in Asia, however utilization and adherence to migraine-specific treatment is relatively low. Access to effective treatments remains a significant unmet medical need for migraine prevention in Asia" said Johan Luthman, EVP and Head of R&D at Lundbeck. "The data from SUNRISE is consistent with previous results across diverse populations and will be pivotal for our efforts to expand access to eptinezumab for patients in Asia suffering with severe migraine." The double-blind, pivotal, SUNRISE trial (n=983) met all key primary and secondary endpoints, with eptinezumab demonstrating greater reductions in migraine frequency, the proportion of migraine attacks with severe pain, and disease burden, compared to placebo.1 "The SUNRISE trial marks a significant step forward in the mission to make migraine-specific preventive treatments more globally accessible, ensuring that patients with severe migraine receive the care they need" said Dr Patricia Pozo-Rosich, Head of Section of the Neurology Department, Director of Headache and Craniofacial Pain Clinical Unit and the Migraine Adaptive Brain Center at the Vall d'Hebron University Hospital in Barcelona, and principal investigator in the SUNRISE trial. In the SUNRISE trial, patients receiving eptinezumab experienced significantly fewer monthly migraine days (MMDs), with eptinezumab offering a -7.5 (300 mg) and -7.2 (100 mg) reduction in MMDs from week 1 through to 12, versus -4.8 with placebo (baseline MMD = 17, p<0.0001 for both 300 mg and 100 mg vs placebo).1 Amongst other parameters, patients receiving eptinezumab (300 mg or 100 mg) were four times more likely to achieve a reduction of ≥75% in the number of migraine days per month, compared to placebo within the first 4 weeks (p<0.0001).1 In the same study, eptinezumab also demonstrated a rapid onset of preventive efficacy, where more participants reported being free of migraine as early as day 1 after receiving eptinezumab treatment compared to placebo (p<0.002 for 300 mg dose; p<0.01 for 100 mg dose). This clinical efficacy was also reflected in patient reported outcomes where patients reported clinically meaningful improvements which were greater with eptinezumab than with placebo.1 Finally, the safety profile of eptinezumab was generally similar to placebo, previous trials, and to the current labelled safety information in the United States prescribing information and EU Summary of Product Characteristics, with the most common treatment-emergent adverse events being COVID-19 and nasopharyngitis.1 Based on the SUNRISE results, Lundbeck has initiated discussions with relevant regulatory authorities with the aim of making eptinezumab available for people suffering from migraine across Asia. About migraine Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also imposes both a social and financial burden. Migraine has a profound impact on patient functioning including relationships with family/friends, leisure activities, household production and worker productivity. Migraine is one of the most prevalent neurological diseases for which medical treatment is sought, and worldwide, is considered the leading cause of disability for people under the age of 50 and the 2nd leading cause of disability worldwide.3,4 Repeated headache attacks, and often the constant fear of the next one, damage family life, social life and work life. Furthermore, frequent use of acute migraine treatments may leave patients experiencing, or at risk of developing, medication overuse headache. Despite equally high prevalence of migraine in Asia as compared western countries, significant unmet needs remain in terms of sufficient and appropriate diagnosis, and better management and therapies for treatment of migraine in East Asia.5 In China, an estimated 14.3% of adults are living with migraine. From this population, approximately 52.9% will visit hospitals and only 13.8% of them will be diagnosed with migraine.6 About the SUNRISE trial SUNRISE (NCT04921384) is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled phase III trial, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment.2 The study was conducted to support marketing authorization across Asia. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days. Participants were randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo. The double-blind, placebo-controlled treatment period was followed by an extension period where all participants received active treatment to further assess the safety and tolerability of eptinezumab. The total trial duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).1 Participants in Japan completing the SUNRISE trial were offered to continue in the SUNSET trial (NCT05064371) which consisted of an open-label eptinezumab treatment of 60 weeks (five infusions), and a Safety Follow-up Period (8 weeks). The SUNRISE was initiated in May 2021 and was conducted in Mainland China, Georgia, Japan, Poland, Slovakia, South Korea, Spain and Taiwan. In the trial, 983 participants were randomized to receive eptinezumab 100 mg or 300 mg or placebo by intravenous (IV) infusion.2 About Vyepti® (eptinezumab) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was intentionally designed for IV administration. The efficacy and safety of eptinezumab was evaluated in two phase III clinical trials (PROMISE-1 in episodic migraine7 and PROMISE-2 in chronic migraine8), where eptinezumab met its primary endpoint of decrease in MMDs over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of eptinezumab as early as day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. Vyepti® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide. Contacts Marie Petterson Jens Høyer Head of Media Relations, Corp. Communication Vice President, Head of Investor Relations MEEP@ JSHR@ +45 29 82 21 82 +45 30 83 45 01Palle Holm OlesenVice President, Investor RelationsPALO@ 30 83 24 26 About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: Yu S, ePresentation at EAN Congress 2025 H. Lundbeck A/S. Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (Sunrise). NCT04921384 Steiner TJ, Stovner LJ, Vos T. et al. J Headache Pain 2018; 19: 17. Leonardi M, Steiner TJ, Scher AT, Lipton RB. J Headache Pain. 2005; 6(6): 429– 440. Takeshima, T, et al. J Headache Pain 2019; 20, 111 Guidelines for the diagnosis and treatment of migraine in China (2022 edition). Chinese Journal of Pain Medicine 2022, 28 (12) Ashina M, et al. Cephalalgia. 2020 Mar;40(3):241-254. Lipton RB, et al. Neurology. 2020 Mar 31;94(13):e1365-e1377. CONTACT: H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark+45 3630 1311info@ This information was brought to you by Cision The following files are available for download: EAN 2025 Press Release SUNRISE_Final View original content:
Yahoo
2 days ago
- Health
- Yahoo
Lundbeck Advances Leadership in Migraine With New Data at the American Headache Society 67th Annual Scientific Meeting
In a post-hoc analysis of the DELIVER trial, interictal periods were longer with VYEPTI compared to placebo and corresponded to higher patient-reported quality of life outcomes Individuals taking VYEPTI consistently had high, long-term retention rates across studies with anti-CGRP monoclonal antibodies, as seen in a post-hoc analysis across selected phase 3 clinical trials Interim data analysis from the INFUSE study showed most patients surveyed generally had low levels of concern about initiating an intravenous (IV) treatment and reported a positive experience Insights from patient perspectives on migraine symptomology from the anti-PACAP HOPE trial exit interviews support need for comprehensive assessments to better understand the full disease burden, including its cognitive impact DEERFIELD, Ill., June 19, 2025--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S, today announced it will present one oral and eight poster presentations at the 67th Annual Scientific Meeting of the American Headache Society (AHS) in Minneapolis from June 19-22, 2025. The data presentations reinforce the need to look beyond monthly migraine days (MMDs) and the importance of a holistic approach to migraine care as suggested by data from eptinezumab-jjmr post-hoc analyses. VYEPTI® (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. "Migraine disease affects over 40 million people in the U.S.,1 profoundly impacting every aspect of life for many," said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. "Lundbeck is energized to be at AHS, driving conversations on how we can better understand the holistic burden of migraine and redefine how we approach care. Our focus goes beyond just alleviating individual symptoms—we are committed to improving the overall quality of life for people living with migraine disease." Analyses presented at AHS from several studies including clinical trials and real-world research continue to focus on novel ways to assess VYEPTI and study results and advance preventive migraine care: P-341: Eptinezumab Treatment was Associated with Longer Interictal Periods and Corresponding Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial: Individuals living with migraine who have longer periods of time between migraine attacks (interictal periods) may experience a reduced overall burden of migraine. A post-hoc analysis of the phase 3b DELIVER trial during weeks 1-12 (n=853) and weeks 1-24 (n=832) evaluated the association between the mean longest interictal period and improvements in patient-reported quality of life (QoL) outcomes. Results from this post-hoc analysis indicate the mean longest interictal period was larger with VYEPTI than as reported by patients receiving placebo during the first 24 weeks of the DELIVER trial. Among participants with >14- and >21-day mean longest interictal periods, a greater proportion of participants achieved clinically meaningful improvements in the 6-item Headache Impact test score (HIT-6; ≥5-point total score reduction) and Patient Global Impression of Change (PGIC; "much improved" or "very much improved" rating) with VYEPTI compared with placebo.2 P-333: Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention: Researchers analyzed select phase 3 clinical trials to assess retention rates for adult participants who were treated with VYEPTI and other anti-CGRP mAbs for the prevention of migraine, including long-term eptinezumab trials: the 104-week, open label, single-arm PREVAIL trial and the 72-week DELIVER trial. In this retrospective cohort study of US claims data, VYEPTI showed high, long-term retention rates for preventive treatment in participants with chronic migraine and in those with migraine for whom 2-4 prior migraine preventive treatments have failed, suggesting a high level of participant satisfaction with continued treatment of VYEPTI. Similar results were observed in other anti-CGRP mAbs in this treatment group.3 P-332: Baseline Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive Anti-CGRP Treatment Had Failed: Interim Results of an Ongoing Real-World Study: INFUSE is an ongoing, non-interventional, prospective study in individuals with migraine initiating VYEPTI for the preventive treatment of migraine. In an interim analysis of the first 75 participants entering the INFUSE study, results indicate that individuals, despite having ≥1 prior a-CGRP preventive treatment, reported a long history of disease and high disease burden (with regard to frequency, severity and cognitive impairments). Interim results also showed that the level of concern about initiating an intravenous (IV) treatment was low and participants in the study generally had a positive infusion experience.4 Further highlighting our commitment to pushing the boundaries on migraine care with preventive treatments, Lundbeck also will host a symposium titled, "Why the interictal period matters: Striving for migraine freedom" with Dr. Amaal Starling and Dr. Stewart Tepper on Thursday, June 19 from 12:30 p.m. to 1:15 p.m. CT. "For optimal migraine management, it's important to prioritize continuous improvement and a patient-centered approach," said Dr. Amaal Starling, Neurologist, Mayo Clinic. "These studies highlight the real-world impact of preventive migraine treatments that can provide sustained control, which may allow individuals to focus on their personal goals and live their lives to the fullest." Additional migraine data being presented at AHS include: IOR-02 (Oral): Patient Perspectives of Migraine Symptomology: Insights from Exit Interviews from the anti-PACAP Antibody Phase 2 HOPE Trial for Migraine Prevention5 P-299: Associated Long-Term Clinical Improvements Following ≥50% Migraine Response and Sustained ≥50% and ≥75% Migraine Reductions in Early Responders to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analyses of the DELIVER Trial6 P-320: Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post Hoc Analysis of the Phase 3 PREVAIL Study7 P-319: Impact of Participant-reported ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Results of the REVIEW Real-world Study of Adults With Chronic Migraine Treated with Eptinezumab8 P-297: Eptinezumab and Patient Education in Chronic Migraine and Medication-overuse Headache: Results from the Randomized, Placebo-controlled RESOLUTION Trial9 P-308: Efficacy and Safety of Eptinezumab in Chronic Migraine: A Randomized Placebo-controlled Trial in a Predominantly Asian Population10 About VYEPTI® VYEPTI® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions. VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. INDICATION VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy. Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. Raynaud's Phenomenon: Development of Raynaud's phenomenon and recurrence or worsening of pre-existing Raynaud's phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud's phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud's phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. ADVERSE REACTIONS The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit About Migraine DiseaseMigraine is a complex and disabling neurological disease that limits functionality and quality of life.1 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.1,11 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.12,13 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.1 It is the second leading cause of years lived with disability (YLD) among all diseases and is the top YLD cause among people aged 15 to 49 years, according to the Global Burden of Disease study. The impact of migraine permeates into career, home life and relationships.14 About INFUSE studyINFUSE is an ongoing, non-interventional, prospective study in individuals with migraine, initiating preventive treatment with eptinezumab-jjmr. Eligible participants were recruited by two infusion center networks and are being followed for 12 months after initiating eptinezumab-jjmr treatment. INFUSE includes adults ≥18 years of age with a diagnosis of migraine who tried ≥1 preventive a-CGRP treatment (erenumab, fremanezumab, galcanezumab, atogepant, or rimegepant [prescribed every other day]). About DELIVER studyDELIVER (NCT04418765) is a phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of eptinezumab-jjmr in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians´ confirmation specific to each treatment in the past 10 years. In the study, 892 patients were randomized to receive eptinezumab-jjmr 100 mg or 300 mg or placebo by IV infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of eptinezumab-jjmr vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, healthcare resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI). The safety and tolerability of eptinezumab-jjmr in the DELIVER study were similar to placebo and consistent with findings from previous eptinezumab-jjmr clinical trials. In DELIVER and earlier eptinezumab-jjmr studies, upper respiratory tract infection, nasopharyngitis, dizziness, and fatigue were the most commonly reported treatment-emergent adverse events (TEAEs). About PREVAIL studyPREVAIL was a phase 3, open-label multi-site U.S.-based study that evaluated eptinezumab-jjmr 300 mg intravenous administration in 128 adults with chronic migraine (CM). PREVAIL included two treatment phases: the primary treatment phase included four infusions of eptinezumab-jjmr 12 weeks apart (Day 0, and Weeks 12, 24, and 36); the secondary treatment phase included up to four additional eptinezumab-jjmr infusions 12 weeks apart (Weeks 48, 60, 72, and 84). Further, patients were followed for 20 additional weeks after the final infusion until Week 104. The PREVAIL study evaluated the long-term safety of repeat doses of eptinezumab-jjmr 300 mg in patients with CM, as well as the pharmacokinetics, immunogenicity, and patient-reported outcomes (PROs). Patient-reported outcome measures included the Migraine Disability Assessment (MIDAS) questionnaire, patient-identified most bothersome symptom (PI-MBS) associated with migraine, Patient Global Impression of Change (PGIC), and 6-item Headache Impact Test (HIT-6). About a-PACAPa-PACAP monoclonal antibody is an investigational compound currently under development (phase 2) for the treatment of migraine. The compound is not commercially available globally. About LundbeckLundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) ("Lundbeck"), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit and connect with us on LinkedIn and X at @LundbeckUS. References 1 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64(5), 516–532. 2 Tepper, Stewart J., Joshi, Shivang, Hirman, Joe, et al. Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life in Participants With Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial. Available at Accessed June 4, 2025.3 Blumenfeld, Andrew, Patel, Foram, Kapur, Neha, et al. Retention Rates Across Clinical Trials of Anti-CGRP Monoclonal Antibodies for Migraine Prevention. Available at Accessed June 4, 2025.4 Starling, Amaal, Regnier, Stephane, Soni-Brahmbhatt, Seema, et al. Characteristics and Eptinezumab Infusion Experience in Participants in Whom ≥1 Prior Preventive anti-CGRP Treatment had Failed: Interim Results of an Ongoing Real-world Study. Available at Accessed June 4, 2025.5 Lipton, Richard B., IOR-02 - Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody phase 2 HOPE trial for migraine prevention. Available at Accessed June 4, 2025.6 Ailani, Jessica, Ashina, Messoud, Awad, Susanne F., et al. Long-term Improvements Following ≥50% Migraine Response to Eptinezumab Treatment in Participants With Migraine: Post Hoc Analysis of the DELIVER Trial. Available at Accessed June 4, 2025.7 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at Accessed June 4, 2025.8 Starling, Amaal, Kudrow, David, Kapur, Neha, et al. Sustained Reductions in Monthly Headache Days with Long-Term Eptinezumab Treatment for Chronic Migraine: Post-Hoc Analysis of the Phase 3 PREVAIL Study. Available at Accessed June 4, 2025.9 Jensen, Rigmor H., Lundqvist, Christofer, Schytz, Henrik W., et al. Eptinezumab and patient education in chronic migraine and medication-overuse headache: Results from the randomized, placebo-controlled RESOLUTION trial. Available at Accessed June 13, 202510 Yu, Shengyuan, Matsumori, Yasuhiko, Kim, Byung-Kun, et al. Efficacy and safety of eptinezumab in chronic migraine: A randomized placebo-controlled trial in a predominantly Asian population. Available at Accessed June 13, 2025.11 National Institute of Neurological Disorders and Stroke. Migraine. Available at: Accessed March 28, 2024.12 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016 [published correction] appears in Lancet. 2017;390(10100):1211-1259.13 American Headache Society. Headache. 2019; 59: 1–18.14 Buse DC, Fanning KM, Reed ML, et al. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019;59(8):1286-1299. doi: View source version on Contacts Brittany KorbDirector, Product Communications and Patient Advocacybrkr@
Medscape
28-05-2025
- General
- Medscape
Eptinezumab for Episodic Cluster Headache Prevention
Compared with placebo, eptinezumab failed to significantly reduce the number of episodic cluster headache (ECH) attacks but showed higher responder rates and improved quality-of-life measures. METHODOLOGY: Eptinezumab, an anti–calcitonin gene-related peptide monoclonal antibody, was evaluated for the treatment of ECH. This phase 3, double-blind, placebo-controlled trial (ALLEVIATE) was conducted across 64 sites in 18 countries from December 2020 to October 2023 and screened 628 adults with ECH. A total of 231 adults (aged 18-75 years; mean age, 44 years; 78% men) meeting the criteria (a history of ECH for 1 or more years and seven or more CH attacks during screening) were randomly assigned to receive either eptinezumab 400 mg (n = 113) or placebo (n = 118) via intravenous infusion. After the 4-week placebo-controlled phase, participants who received placebo transitioned to delayed-start active treatment for an additional 4 weeks, followed by 12 weeks of observation and an 8-week safety follow-up. The primary outcome was the change from baseline in the number of weekly attacks (weeks 1-2), assessed via a daily electronic diary; secondary outcomes included responder rates of 50% or greater/75% or greater; pain severity; change in disease status, assessed using the Patient Global Impression of Change (PGIC); quality of life, assessed using the Sleep Impact Scale; participant well-being, assessed using the EQ-5D-5L; and self-rated productivity, assessed using the Work Productivity and Activity Impairment. TAKEAWAY: No significant reduction in the number of weekly attacks were observed with eptinezumab vs placebo during weeks 1 and 2 (least-square mean difference, 0.7; P = .50). = .50). A higher proportion of eptinezumab-treated participants achieved 50% or greater response than placebo-treated participants over week 2 (50.9% vs 37.3%; odds ratio [OR], 1.77; P = .04), week 3 (62.5% vs 43.8%; OR, 2.26; P = .004), and week 4 (66.7% vs 50.5%; OR, 2.14; P = .009). = .04), week 3 (62.5% vs 43.8%; OR, 2.26; = .004), and week 4 (66.7% vs 50.5%; OR, 2.14; = .009). Compared with placebo, eptinezumab demonstrated improvements for 75% or greater responder rates by week 4 (35.5% vs 52.0%; OR, 1.98; P = .02). = .02). Numerically greater improvements were observed with eptinezumab than with placebo in terms of PGIC scores, EQ-5D-5L visual analog scale scores (mean difference, 7.8 points; P = .02), and sleep/activity metrics. = .02), and sleep/activity metrics. Treatment-emergent adverse events were similar between eptinezumab and placebo (25.0% and 26.5%, respectively), confirming tolerability. IN PRACTICE: "Among adults with episodic cluster headache, eptinezumab did not significantly reduce the number of attacks vs placebo, although it was associated with numerically higher responder rates and improvements in average daily pain and patient-reported outcomes. Eptinezumab was generally well tolerated," the authors of the study wrote. SOURCE: This study was led by Rigmor H. Jensen, Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark. It was published online on May 19 in JAMA Neurology . LIMITATIONS: T he study's generalisability may be limited due to the predominantly male (78%) and European population. Early termination due to futility reduced the sample size, although the cohort remained sufficient for the primary analysis. The 4-week placebo-controlled period was too brief to assess the long-term efficacy, unlike the 12-week regimens used for migraine prevention. DISCLOSURES: This trial was sponsored and funded by H. Lundbeck A/S, including medical writing support. Jensen reported receiving grants from Københavns Universitet, Lundbeck Pharma, Novo Nordisk, and Lundbeck Foundation paid to the institution during the conduct of the study. Additional disclosures are noted in the original article.
