Latest news with #JohanLuthman
Yahoo
17 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
04-04-2025
- Health
- Yahoo
Lundbeck to present positive pipeline data at American Academy of Neurology (AAN) Annual Meeting
VALBY, Denmark, April 4, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present positive interim results from the open-label extension of the PACIFIC trial investigating bexicaserin, in addition to new analyses from clinical trials and real-world data with eptinezumab. H. Lundbeck A/S (Lundbeck) today announced that recent pipeline data will be presented at the 2025 AAN Annual Meeting in San Diego, U.S. The data includes an oral presentation of the six-month results from the open-label extension (OLE) of the Phase 1b/2a PACIFIC trial of bexicaserin, a novel treatment under development for seizures associated with Developmental and Epileptic Encephalopathies (DEEs).1 DEEs are the most severe group of epilepsies characterized by drug-resistant seizures, and developmental slowing or regression.2 "DEEs can be caused by a range of acquired, syndromal, and genetic etiologies, with more than 900 genes implicated. However, only a few subtypes currently have approved therapies, leaving many patients in need. The DEE-inclusive PACIFIC trial and six-month OLE data indicate that bexicaserin may be able to help address this unmet need across multiple DEE types, and highlights Lundbeck's expanding commitment to the neuro-rare space. We look forward to engaging with the global neuroscience community at AAN to discuss the data and potential of bexicaserin to support patients, caregivers and healthcare professionals in the management of DEEs," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. The OLE included patients who successfully completed the PACIFIC trial3 and was designed to evaluate the long-term safety (up to 52 weeks), tolerability, and efficacy of bexicaserin in a cohort of participants with DEEs who were newly exposed to bexicaserin for at least 6 months.1 The OLE interim analysis showed that bexicaserin continues to exhibit a favourable safety and tolerability profile at six months, consistent with the safety profile observed during the PACIFIC trial. All bexicaserin treatment-naive patients (n=9) successfully transitioned from placebo to bexicaserin, reinforcing the tolerability of bexicaserin in an inclusive DEE population. In this placebo-bexicaserin switch population, a 57.3% reduction in countable motor seizures and 61.2% reduction in total seizures was observed, consistent with the response in non-naive participants at 6 months (n=32).* Moreover, more than half of patients newly exposed to bexicaserin (n=5/9) experienced a ≥50% reduction from baseline in countable motor seizures.1* In addition, Lundbeck will present recent post-hoc analyses and real-world data for eptinezumab investigating meaningful endpoints, such as good days per month†, and sustained treatment response. Lundbeck remains focused on raising the bar around preventive treatment expectations in migraine and increasing the understanding of the holistic impact of migraine on quality of life. *As compared to baseline at entry into PACIFIC study. †As reported by trial patients based on individual migraine experience Details of Lundbeck presentations at AAN 2025: Bexicaserin Oral Presentation Monday, April 7, Session S20, 4:18 – 4:30pm PT Title: Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension Eptinezumab Poster Presentations: Title: Long-term Maintenance of ≥50% and ≥75% Migraine Response With Eptinezumab in Patients With High-frequency Episodic Migraine and Chronic Migraine and 2-4 Prior Migraine Preventive Treatment Failures4 I Poster number: P12.005 Title: Patient-reported Impact of ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Real-world Study of Adults With Chronic Migraine Treated With Eptinezumab5 I Poster number: P12.010 Title: Long-term Reductions in Monthly Headache Days With Eptinezumab Treatment in Adults With Chronic Migraine: Results From the PREVAIL Study6 I Poster number: P12.003 About Bexicaserin Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. It is being evaluated in a global Phase III clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older. Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The PACIFIC trial was a randomised, double-blind, placebo-controlled, DEE-inclusive trial (NCT05364021) in 52 participants with Dravet syndrome, Lennox-Gastaut syndrome, or DEE Other, who had ≥4 countable motor seizures during the 28-day baseline period, and who were on a stable regimen of 1 to 4 concomitant antiseizure medications.3 About eptinezumab (Vyepti®) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of eptinezumab 100 mg and 300 mg was investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program observed 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. Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE-1 and PROMISE-2 experienced nasopharyngitis. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. Eptinezumab 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 Medicines Agency (EMA) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in the U.S. market, as well as in more than 30 markets worldwide. Contacts Marie Petterson Jens Høyer Media Relations Lead, 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 5,500 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: 1. American Academy of Neurology Annual Meeting 2025. Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension. 2. Sheffer I, et al. Epilepsia. 2025 Feb 10.1111/epi.18265. 3. Kaye R, et al. Efficacy and safety of bexicaserin (LP352) in adolescent and adult participants with developmental and epileptic encephalopathies: Results of the phase 1b/2a PACIFIC study. Presented at the Annual Meeting of the American Academy of Neurology; April 13-18, 2024 4. Ailani J, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. 5. Argoff C, et al. Poster presentation. American Academy of Neurology Annual Meeting 2025. 6. Starling A, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. 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: Lundbeck AAN_ Final View original content: SOURCE H. Lundbeck A/S Sign in to access your portfolio
Yahoo
16-02-2025
- Business
- Yahoo
Lundbeck gains FDA fast track designation for MSA therapy amlenetug
Lundbeck has received the US Food and Drug Administration's (FDA) fast track designation for its investigational drug amlenetug, a potential treatment for multiple system atrophy (MSA). The designation will provide Lundbeck with the possibility of rolling reviews and detailed guidance to streamline the drug development process. The decision is supported by the outcomes from the Phase II AMULET trial. Lundbeck research and development head and executive vice-president Johan Luthman stated: 'We are pleased that amlenetug has received fast track designation for the potential treatment of MSA. This is a step forward in our commitment to address significant unmet needs in this devastating disease.' The drug previously secured the orphan drug designation in the US and from the European Medicines Agency in April 2024 and May 2021 respectively, as well as Japan's Ministry of Health, Labour and Welfare's SAKIGAKE ("pathfinder") designation in March 2023. A human monoclonal antibody, amlenetug is designed to target and bind to extracellular α-synuclein, aiming to prevent its uptake and block aggregation seeding. The active Fc region of the drug may also promote the immune-mediated clearance of α-synuclein via microglia-mediated uptake. Being developed under a joint research and licensing agreement between Lundbeck and Genmab, the drug is being assessed by Lundbeck in the Phase III MASCOT trial to evaluate its safety and efficacy in MSA patients. The randomised, interventional, double-blind, placebo-controlled, parallel-group, optional open-label extension trial will be conducted in Europe, North America and Asia. In a strategic move to enhance its presence in the neuro-rare disease sector, Lundbeck completed the acquisition of Longboard Pharmaceuticals in December 2024, securing all its outstanding shares. "Lundbeck gains FDA fast track designation for MSA therapy amlenetug" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
