Eisai completes rolling BLA submission for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
BioArctic AB's partner Eisai has completed a rolling Biologics License Application (BLA) submission to the FDA for Leqembi subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The autoinjector would allow for 15-second home administration after completing the initial IV phase. The application is based on Clarity AD open-label extension study data. Leqembi is currently approved in multiple countries including the US, Japan, and China, with pending applications in 10 other regions. The FDA is also reviewing a separate application for monthly IV maintenance dosing with a PDUFA date of January 25, 2025.
BioArctic AB ha annunciato che il suo partner Eisai ha completato la presentazione di una domanda di Licenza Biologica (BLA) in via continua alla FDA per il Leqembi in autoiniettore sottocutaneo, destinato a dosaggi di mantenimento settimanali nella terapia per la malattia di Alzheimer precoce. Questo autoiniettore consentirebbe l'amministrazione domestica in 15 secondi dopo aver completato la fase intravenosa iniziale. La domanda si basa sui dati dello studio di estensione open-label Clarity AD. Leqembi è attualmente approvato in diversi paesi, tra cui Stati Uniti, Giappone e Cina, con domande pendenti in altre 10 regioni. La FDA sta anche esaminando una domanda separata per dosaggi di mantenimento intravenoso mensile con una data PDUFA del 25 gennaio 2025.
BioArctic AB ha anunciado que su socio Eisai ha completado una presentación continua de Solicitud de Licencia Biológica (BLA) a la FDA para el autoinyector subcutáneo de Leqembi destinado a dosificación de mantenimiento semanal en el tratamiento de la enfermedad de Alzheimer en sus primeras etapas. Este autoinyector permitiría la administración en casa en 15 segundos después de completar la fase intravenosa inicial. La solicitud se basa en los datos del estudio de extensión open-label Clarity AD. Leqembi está actualmente aprobado en múltiples países, incluidos EE. UU., Japón y China, con solicitudes pendientes en otras 10 regiones. La FDA también está revisando una solicitud separada para dosificación de mantenimiento intravenosa mensual, con una fecha PDUFA del 25 de enero de 2025.
BioArctic AB의 파트너인 Eisai가 초기 알츠하이머병 치료를 위한 주간 유지 요법을 위한 Leqembi 피하 자가 주사기와 관련하여 FDA에 롤링 생물학적 면허 신청(BLA)을 제출 완료했습니다. 이 자가 주사기는 초기 IV 단계가 완료된 후 15초 만에 자택에서 주사가 가능하게 합니다. 신청서는 Clarity AD 오픈 레이블 확장 연구 데이터를 바탕으로 하고 있습니다. Leqembi는 현재 미국, 일본, 중국을 포함한 여러 국가에서 승인되어 있으며, 다른 10개 지역에서 신청이 진행 중입니다. FDA는 또한 2025년 1월 25일 PDUFA 날짜를 가진 월별 IV 유지 요법에 대한 별도의 신청을 검토하고 있습니다.
BioArctic AB a annoncé que son partenaire Eisai a terminé la soumission d'une demande de Licence Biologique (BLA) à la FDA pour l'autoinjecteur subcutané Leqembi, destiné à une administration de maintien hebdomadaire dans le traitement de la maladie d'Alzheimer à un stade précoce. Cet autoinjecteur permettrait une administration à domicile en 15 secondes après avoir terminé la phase IV initiale. La demande est basée sur les données de l'étude d'extension en ouvert Clarity AD. Leqembi est actuellement approuvé dans plusieurs pays, y compris les États-Unis, le Japon et la Chine, avec des demandes en attente dans 10 autres régions. La FDA examine également une demande distincte pour un dosage IV de maintien mensuel, avec une date PDUFA fixée au 25 janvier 2025.
BioArctic AB hat bekannt gegeben, dass der Partner Eisai einen fortlaufenden Antrag auf biologisches Lizenzverfahren (BLA) bei der FDA für den subkutanen Autoinjektor von Leqembi zur wöchentlichen Erhaltungsdosierung in der Frühtherapie von Alzheimer abgeschlossen hat. Der Autoinjektor würde eine 15-sekündige Selbstadministration nach der initialen IV-Phase ermöglichen. Der Antrag basiert auf den Daten der Clarity AD Open-Label-Verlängerungsstudie. Leqembi ist derzeit in mehreren Ländern genehmigt, darunter die USA, Japan und China, mit ausstehenden Anträgen in 10 weiteren Regionen. Die FDA prüft ebenfalls einen separaten Antrag für eine monatliche IV-Erhaltungsdosierung mit einem PDUFA-Datum vom 25. Januar 2025.
- Fast Track designation received from FDA for subcutaneous autoinjector
- Potential for convenient home administration with 15-second injection time
- Broad global market presence with approvals in 8 countries
- Pending applications in 10 additional regions including EU
- Still requires initial IV administration phase before subcutaneous maintenance
- FDA approval timeline not yet determined
Insights
The completion of the rolling BLA submission for Leqembi's subcutaneous maintenance dosing represents a significant milestone in Alzheimer's disease treatment. The autoinjector format could revolutionize treatment delivery by enabling at-home administration in just 15 seconds, compared to current IV infusions. This advancement could substantially reduce healthcare system burden and improve treatment adherence.
The subcutaneous formulation maintains effective drug concentrations for protofibril clearance, which is important as data suggests continued treatment benefits even after plaque removal. This development could significantly impact
This regulatory development carries substantial market implications. The subcutaneous autoinjector could significantly expand Leqembi's market penetration by addressing key treatment barriers. Key advantages include:
- Reduced healthcare facility visits
- Lower nursing care requirements
- Improved treatment convenience
- Potential cost savings in administration
With Alzheimer's affecting millions globally and effective treatment options, a more convenient administration method could drive broader adoption. The fast-track designation suggests regulatory confidence, while the extensive global approval status strengthens the commercial outlook. For BioArctic, this development could enhance their position in the Nordic market and potentially increase their partnership value.
The BLA is based on data from the Clarity AD open-label extension (OLE) study and modeling of observed data. If the application is approved by the FDA, the Leqembi autoinjector could be used to administer Leqembi at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils[1],[2] which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.
AD is an ongoing neurotoxic process that begins before and continues after plaque deposition. Data suggest that early and continuing treatment may prolong the benefit even after plaque is cleared from the brain. This SC autoinjector is expected to be easier for patients and their care partners to use and may reduce the need for hospital visits and nursing care compared to IV administration. In addition to potentially maintaining the clinical and biomarker benefits, subcutaneous maintenance dosing may be more convenient for patients and their care partners to continue the treatment.
Leqembi is approved in the
Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. 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 and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
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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 person below, on November 1, 2024, at 00:30 a.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 (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
Please find full US prescribing information here including Boxed WARNING.
Lecanemab marketed in 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] Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
[2] Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706
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