CHMP has adopted a negative opinion on lecanemab for the EU
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on BioArctic AB's partner Eisai's Marketing Authorization Approval (MAA) for lecanemab, a treatment for Alzheimer's disease. This decision affects BioArctic's (Nasdaq Stockholm: BIOA B) potential to commercialize lecanemab in the Nordic region, which was contingent on European approval.
Lecanemab is already approved and marketed in several countries, including the United States, Japan, and China. BioArctic is consulting with Eisai regarding future actions and will provide an update later today. The negative opinion from CHMP represents a significant setback for BioArctic's European market plans for lecanemab in Alzheimer's disease treatment.
Il Comitato per i Prodotti Medicinali per Uso Umano (CHMP) dell'Agenzia Europea per i Medicinali (EMA) ha adottato un parere negativo sulla Richiesta di Autorizzazione alla Commercializzazione (MAA) di lecanemab, un trattamento per la malattia di Alzheimer, sviluppato dal partner di BioArctic AB, Eisai. Questa decisione influisce sulla possibilità di BioArctic (Nasdaq Stoccolma: BIOA B) di commercializzare lecanemab nella regione nordica, che dipendeva dall'approvazione europea.
Lecanemab è già approvato e commercializzato in diversi paesi, tra cui Stati Uniti, Giappone e Cina. BioArctic sta consultando Eisai riguardo alle azioni future e fornirà un aggiornamento più tardi oggi. Il parere negativo del CHMP rappresenta un notevole ostacolo ai piani di BioArctic per il mercato europeo riguardanti il trattamento della malattia di Alzheimer con lecanemab.
El Comité de Productos Medicinales de Uso Humano (CHMP) de la Agencia Europea de Medicamentos (EMA) ha adoptado un dictamen negativo sobre la Solicitud de Autorización de Comercialización (MAA) de lecanemab, un tratamiento para la enfermedad de Alzheimer, del socio de BioArctic AB, Eisai. Esta decisión afecta la capacidad de BioArctic (Nasdaq Estocolmo: BIOA B) para comercializar lecanemab en la región nórdica, ya que estaba condicionada a la aprobación europea.
Lecanemab ya está aprobado y comercializado en varios países, incluidos Estados Unidos, Japón y China. BioArctic está consultando con Eisai sobre futuras acciones y proporcionará una actualización más tarde hoy. El dictamen negativo del CHMP representa un significante revés para los planes de BioArctic en el mercado europeo para lecanemab en el tratamiento de la enfermedad de Alzheimer.
유럽의약청(EMA) 의약품사용자문위원회(CHMP)는 BioArctic AB의 파트너 Eisai의 알츠하이머병 치료제인 레카네맙의 마케팅 허가 신청(MAA)에 대해 부정적인 의견을 채택했습니다. 이러한 결정은 BioArctic(Nasdaq 스톡홀름: BIOA B)의 레카네맙 상용화 가능성에 영향을 미치며, 이는 유럽의 승인을 조건으로 했습니다.
레카네맙은 이미 미국, 일본, 중국 등 여러 국가에서 승인 및 판매되고 있습니다. BioArctic는 향후 조치에 대해 Eisai와 협의 중이며 오늘 늦게 업데이트를 제공할 예정입니다. CHMP의 부정적인 의견은 알츠하이머병 치료를 위한 레카네맙의 BioArctic의 유럽 시장 계획에 상당한 차질을 의미합니다.
Le Comité des Médicaments à Usage Humain (CHMP) de l'Agence Européenne des Médicaments (EMA) a adopté un avis défavorable concernant la Demande d'Autorisation de Mise sur le Marché (MAA) de lecanemab, un traitement pour la maladie d'Alzheimer, proposé par le partenaire de BioArctic AB, Eisai. Cette décision a des implications pour la capacité de BioArctic (Nasdaq Stockholm : BIOA B) à commercialiser lecanemab dans la région nordique, qui dépendait de l'approbation européenne.
Lecanemab est déjà approuvé et commercialisé dans plusieurs pays, y compris les États-Unis, le Japon et la Chine. BioArctic consulte Eisai sur les actions futures et fournira une mise à jour plus tard dans la journée. L'avis négatif du CHMP représente un revers significatif pour les plans de BioArctic sur le marché européen concernant le traitement de la maladie d'Alzheimer avec lecanemab.
Das Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittel-Agentur (EMA) hat eine negative Stellungnahme zur Zulassungsantrag (MAA) für Lecanemab, eine Behandlung der Alzheimer-Krankheit, des Partners von BioArctic AB, Eisai, angenommen. Diese Entscheidung wirkt sich auf die Möglichkeit von BioArctic (Nasdaq Stockholm: BIOA B) aus, Lecanemab in der nordischen Region zu vermarkten, was von der europäischen Genehmigung abhängig war.
Lecanemab ist bereits in mehreren Ländern genehmigt und vermarktet worden, darunter die Vereinigten Staaten, Japan und China. BioArctic konsultiert Eisai bezüglich zukünftiger Maßnahmen und wird heute später ein Update bereitstellen. Die negative Stellungnahme des CHMP stellt einen erheblichen Rückschlag für die europäischen Marktpläne von BioArctic für Lecanemab in der Behandlung der Alzheimer-Krankheit dar.
- Lecanemab is already approved and marketed in multiple countries including the US, Japan, and China
- BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval
- CHMP adopted a negative opinion on Eisai's Marketing Authorization Approval for lecanemab in the EU
- The negative opinion affects BioArctic's potential to commercialize lecanemab in the Nordic region
- European market entry for lecanemab is now uncertain or delayed
Insights
The CHMP's negative opinion on lecanemab for the EU market is a significant setback for BioArctic and Eisai. This decision could have substantial implications for both companies' European market strategies and revenue projections.
Key points to consider:
- Lecanemab's approval in major markets like the US, Japan and China suggests its potential. The EU rejection raises questions about differing regulatory standards or data interpretations.
- The Nordic region commercialization plans for BioArctic are now in jeopardy, potentially impacting future revenue streams.
- Eisai's next steps, such as appealing the decision or conducting additional studies, will be important for the drug's future in Europe.
- This setback might affect investor confidence in BioArctic's pipeline and partnership strategy.
While the negative opinion is a blow, it's important to note that lecanemab is already generating revenue in other major markets. The overall impact on BioArctic will depend on the EU market's significance in their global strategy and their ability to address CHMP's concerns.
The CHMP's negative opinion on lecanemab is a surprising development, given its approval in other major markets. This decision raises important questions about the drug's efficacy and safety profile in the context of European standards.
From a clinical perspective:
- The divergence in regulatory decisions between the EU and other regions suggests potential differences in data interpretation or risk-benefit assessment.
- This could reflect variations in patient populations, treatment protocols, or specific concerns about the drug's mechanism of action.
- The decision might also indicate a more cautious approach by European regulators towards new Alzheimer's treatments, given the complex nature of the disease and previous disappointments in this therapeutic area.
For Alzheimer's patients in Europe, this decision delays access to a potentially beneficial treatment. However, it also underscores the importance of rigorous safety and efficacy standards in neurodegenerative disease therapies. The scientific community will be keen to understand the specific reasons behind CHMP's negative opinion to guide future research and development efforts in this critical field.
The CHMP's negative opinion on lecanemab presents a complex challenge for BioArctic and Eisai's European market access strategy. This decision will have ripple effects across their commercialization plans and potentially impact their global positioning.
Strategic implications to consider:
- BioArctic's plans for Nordic region commercialization are now on hold, necessitating a reassessment of their European market entry strategy.
- The companies may need to allocate additional resources for potential resubmission or new clinical trials tailored to European regulatory requirements.
- This setback could lead to a reevaluation of pricing strategies in other markets, as European pricing often serves as a reference for global pricing decisions.
- Competitors in the Alzheimer's space may gain an advantage in the European market, potentially altering the competitive landscape.
The path forward will likely involve intensive engagement with EMA to understand the specific concerns and determine the most efficient route to potential approval. This process could involve additional data analysis, new studies, or changes in the proposed indication. The companies' ability to navigate this setback will be important for their long-term success in the European Alzheimer's treatment market.
Lecanemab is already approved 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 12:40 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.
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