Eisai will seek re-examination of CHMP opinion för lecanemab
BioArctic AB's partner Eisai announced plans to request re-examination of the Committee for Medicinal Products for Human Use (CHMP)'s negative opinion on the Marketing Authorization Approval for lecanemab, an Alzheimer's disease treatment, in the EU. The decision disappoints BioArctic's CEO, Gunilla Osswald, who emphasizes the importance of timely treatment for patients. Eisai has a 60-day period to provide grounds for re-examination, with CHMP having 60 days to respond.
Lecanemab is already approved in several countries, including the US, Japan, and China. Alzheimer's disease affects 6.9 million people in Europe, with projections indicating this number may double by 2050. BioArctic retains commercialization rights in the Nordic region, pending European approval.
BioArctic AB e il suo partner Eisai hanno annunciato l'intenzione di richiedere una riesamina del parere negativo del Comitato per i Medicinali per Uso Umano (CHMP) riguardo all'approvazione della commercializzazione per lecanemab, un trattamento per l'Alzheimer, nell'UE. Questa decisione ha deluso l'amministratore delegato di BioArctic, Gunilla Osswald, che sottolinea l'importanza di un trattamento tempestivo per i pazienti. Eisai ha un periodo di 60 giorni per fornire le motivazioni per la riesamina, mentre il CHMP avrà 60 giorni per rispondere.
Lecanemab è già approvato in diversi paesi, tra cui Stati Uniti, Giappone e Cina. La malattia di Alzheimer colpisce 6,9 milioni di persone in Europa, con previsioni che indicano che questo numero potrebbe raddoppiare entro il 2050. BioArctic mantiene i diritti di commercializzazione nella regione nordica in attesa dell'approvazione europea.
BioArctic AB y su socio Eisai anunciaron planes para solicitar una re-examinación de la opinión negativa del Comité de Medicamentos de Uso Humano (CHMP) sobre la aprobación de autorización de comercialización para lecanemab, un tratamiento para la enfermedad de Alzheimer, en la UE. Esta decisión decepciona a la CEO de BioArctic, Gunilla Osswald, quien enfatiza la importancia de un tratamiento oportuno para los pacientes. Eisai tiene un periodo de 60 días para proporcionar justificaciones para la re-examinación, mientras que el CHMP tendrá 60 días para responder.
Lecanemab ya está aprobado en varios países, incluidos EE. UU., Japón y China. La enfermedad de Alzheimer afecta a 6,9 millones de personas en Europa, con proyecciones que indican que este número podría duplicarse para 2050. BioArctic retiene los derechos de comercialización en la región nórdica, a la espera de la aprobación europea.
BioArctic AB의 파트너인 Eisai가 인간 사용을 위한 의약품 위원회 (CHMP)의 레카네맙에 대한 마케팅 승인에 대한 부정적인 의견 재검토를 요청할 계획을 발표했습니다. 알츠하이머병 치료제인 레카네맙에 대한 부정적인 결정은 BioArctic의 CEO인 Gunilla Osswald을 실망시키며, 환자를 위한 시의적절한 치료의 중요성을 강조합니다. Eisai는 재검토의 근거를 제시할 수 있는 60일의 기간을 가지며, CHMP는 60일의 시간 안에 응답해야 합니다.
레카네맙은 이미 미국, 일본, 중국 등 여러 나라에서 승인되었습니다. 알츠하이머병은 유럽에서 690만 명에게 영향을 미치며, 이 수치는 2050년까지 두 배로 증가할 것으로 예상됩니다. BioArctic은 유럽의 승인을 기다리는 동안 북유럽 지역의 상업화 권리를 보유하고 있습니다.
BioArctic AB et son partenaire Eisai ont annoncé des plans pour demander un réexamen de l'avis négatif du Comité des Médicaments à Usage Humain (CHMP) concernant l'approbation de la mise sur le marché de lecanemab, un traitement contre la maladie d'Alzheimer, dans l'UE. Cette décision déçoit la PDG de BioArctic, Gunilla Osswald, qui souligne l'importance d'un traitement rapide pour les patients. Eisai dispose d'un délai de 60 jours pour fournir des justifications pour le réexamen, le CHMP ayant 60 jours pour répondre.
Lecanemab est déjà approuvé dans plusieurs pays, dont les États-Unis, le Japon et la Chine. La maladie d'Alzheimer touche 6,9 millions de personnes en Europe, et les projections indiquent que ce nombre pourrait doubler d'ici 2050. BioArctic conserve les droits de commercialisation dans la région nordique, en attendant l'approbation européenne.
BioArctic AB und ihr Partner Eisai haben Pläne angekündigt, eine Überprüfung der negativen Stellungnahme des Ausschusses für Humanarzneimittel (CHMP) zur Genehmigung der Vermarktung von Lecanemab, einer Behandlung für Alzheimer, in der EU zu beantragen. Diese Entscheidung enttäuscht die CEO von BioArctic, Gunilla Osswald, die die Bedeutung einer zeitnahen Behandlung für die Patienten betont. Eisai hat einen Zeitraum von 60 Tagen, um Gründe für die Überprüfung vorzulegen, wobei der CHMP 60 Tage Zeit hat, um zu antworten.
Lecanemab ist bereits in mehreren Ländern, darunter die USA, Japan und China, zugelassen. Alzheimer betrifft 6,9 Millionen Menschen in Europa, wobei Prognosen darauf hindeuten, dass sich diese Zahl bis 2050 verdoppeln könnte. BioArctic behält die Kommerzialisierungsrechte in der nordischen Region, während sie auf die europäische Genehmigung wartet.
- Lecanemab is already approved in multiple countries including the US, Japan, and China
- BioArctic has commercialization rights for lecanemab in the Nordic region, pending EU approval
- Eisai and BioArctic are preparing for joint commercialization in the Nordic region
- CHMP issued a negative opinion on lecanemab's Marketing Authorization Approval in the EU
- Delay in potential EU market entry for lecanemab due to re-examination process
- Potential loss of market opportunity in Europe's growing Alzheimer's disease patient population
Insights
The CHMP's negative opinion on lecanemab's Marketing Authorization Approval (MAA) in the EU is a significant setback for Eisai and BioArctic. This decision, while not final, could substantially delay the drug's availability in a important market. The EU represents a sizable opportunity, with
The re-examination process, while offering a second chance, introduces uncertainty and potential delays. This could impact BioArctic's revenue projections, especially considering their commercialization rights in the Nordic region. However, lecanemab's approvals in other major markets like the US, Japan and China provide some cushion.
Investors should note that this setback is primarily a timing issue rather than a fundamental challenge to the drug's efficacy. The strong existing approvals in other regions suggest that lecanemab's long-term prospects remain intact. Nevertheless, this delay could open a window for competitors in the EU market.
From a financial perspective, while immediate EU revenues are now uncertain, the global rollout in approved markets should continue to drive growth. The stock may face short-term pressure, but the long-term thesis for BioArctic remains largely unchanged, albeit with increased regulatory risk in Europe.
The CHMP's negative opinion on lecanemab is unusual given the drug's approval in several other major markets. This divergence highlights the complex regulatory landscape for Alzheimer's treatments in the EU. The re-examination process, while offering a path forward, is not a guarantee of reversal.
Key factors to watch in the re-examination:
- New rapporteurs will be assigned, potentially bringing fresh perspectives.
- Eisai has 60 days to provide grounds for re-examination, allowing them to address specific CHMP concerns.
- The CHMP then has another 60 days to respond, making this a potentially lengthy process.
This situation underscores the importance of robust, region-specific regulatory strategies. Eisai and BioArctic may need to provide additional data or analyses tailored to European regulatory requirements. The outcome of this process could have broader implications for the approval pathway of future Alzheimer's treatments in the EU.
For investors, this highlights the inherent risks in the drug approval process, even for treatments that have gained approval elsewhere. It also emphasizes the value of geographic diversification in drug approvals, as seen with lecanemab's success in other markets.
The CHMP's negative opinion on lecanemab is a surprising development given the drug's demonstrated efficacy in clinical trials and its approval in other major markets. This decision raises questions about the specific criteria and evidence thresholds being applied by European regulators for Alzheimer's treatments.
Lecanemab's mechanism of action, targeting amyloid beta plaques, represents a significant advance in Alzheimer's treatment. Its ability to delay the onset of more severe stages of the disease is a important benefit for patients, potentially extending their quality of life and reducing caregiver burden.
The delay in EU approval could have serious implications for Alzheimer's patients in Europe. With the disease affecting
From a research perspective, this decision might influence the direction of Alzheimer's drug development in Europe. It could potentially shift focus towards alternative treatment approaches or necessitate more extensive European-specific trials for amyloid-targeting therapies.
While the re-examination offers hope, the scientific community and patients alike will be eagerly awaiting the outcome, as it could significantly impact the landscape of Alzheimer's treatment in Europe.
"We are surprised and very disappointed by the CHMP's opinion posted today. Foremost the negative opinion adopted by the CHMP is sad for all patients, caregivers and healthcare professionals in the EU who will now have to wait longer for a treatment which can effectively change the course of this devastating disease. We know that for these patients, time is what they value the most, and potentially denying them a treatment which has been shown to delay the onset of more severe stages of the diseases is of course not what they or we had hoped for," said Gunilla Osswald, BioArctic's CEO. "This is not the final verdict however, and our partner Eisai will seek re-examination of the CHMP opinion and continue work with authorities to ensure this treatment is available for eligible people living with early Alzheimer's disease in the EU as soon as possible."
A formal request for re-examination allows the applicant a 60-day period to provide the CHMP with the grounds for the re-examination request. The CHMP, led by new rapporteurs, will have 60 days to respond.
Lecanemab is already approved in
Alzheimer's disease currently affects 6.9 million people in
Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on July 26, 2024, at 13:15 p.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
About lecanemab (generic name, brand name: Leqembi®)
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the
Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Eisai has also submitted applications for approval of lecanemab in 11 other countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the
Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
[1] European Medicines Agency. Involvement of patients in Scientific Advisory Group and Ad Hoc Expert meetings at EMA. Available at: https://www.ema.europa.eu/system/files/documents/other/involvement_of_patients_in_scientific_advisory_group-en.pdf. Last accessed: June 2024.
[2] European Medicines Agency. The Centralised Procedure at the EMA. Available at: https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-european-medicines-agency_en.pdf. Last accessed: June 2024.
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