FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
BioArctic AB announced that the FDA has accepted their partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. The PDUFA action date is set for August 31, 2025.
Leqembi, indicated for early Alzheimer's disease treatment, could become the only FDA-approved anti-amyloid therapy offering convenient subcutaneous injection with at-home administration. The SC-AI 360 mg weekly maintenance regimen, following the biweekly intravenous initiation phase, is designed to maintain clinical and biomarker benefits with a 15-second injection process.
The treatment is already approved in the US, Japan, China, Great Britain, and received a positive CHMP opinion from EMA in November 2024. This new delivery method could reduce hospital visits and simplify the treatment pathway for Alzheimer's patients.
BioArctic AB ha annunciato che la FDA ha accettato la domanda di licenza biologica (BLA) del partner Eisai per il Leqembi autoiniettore sottocutaneo (SC-AI) per la somministrazione settimanale. La data di azione PDUFA è fissata per il 31 agosto 2025.
Leqembi, indicato per il trattamento precoce dell'Alzheimer, potrebbe diventare l'unica terapia anti-amiloide approvata dalla FDA che offre un'iniezione sottocutanea pratica con somministrazione domestica. Il regime di mantenimento settimanale di 360 mg SC-AI, dopo la fase di avvio endovenoso bisettimanale, è progettato per mantenere i benefici clinici e dei biomarcatori con un processo di iniezione di 15 secondi.
Il trattamento è già approvato negli Stati Uniti, Giappone, Cina, Gran Bretagna e ha ricevuto un parere positivo dal CHMP dell'EMA nel novembre 2024. Questo nuovo metodo di somministrazione potrebbe ridurre le visite ospedaliere e semplificare il percorso di trattamento per i pazienti affetti da Alzheimer.
BioArctic AB anunció que la FDA ha aceptado la solicitud de licencia biológica (BLA) de su socio Eisai para el autoinyector subcutáneo Leqembi (SC-AI) para la dosificación de mantenimiento semanal. La fecha de acción del PDUFA está prevista para el 31 de agosto de 2025.
Leqembi, indicado para el tratamiento de la enfermedad de Alzheimer en etapas tempranas, podría convertirse en la única terapia anti-amiloide aprobada por la FDA que ofrece una inyección subcutánea conveniente con administración en casa. El régimen de mantenimiento semanal de 360 mg SC-AI, después de la fase de inicio intravenoso quincenal, está diseñado para mantener los beneficios clínicos y de biomarcadores con un proceso de inyección de 15 segundos.
El tratamiento ya está aprobado en EE. UU., Japón, China, Gran Bretaña y recibió un dictamen positivo del CHMP de la EMA en noviembre de 2024. Este nuevo método de administración podría reducir las visitas al hospital y simplificar el camino de tratamiento para los pacientes con Alzheimer.
BioArctic AB는 FDA가 파트너 Eisai의 생물학적 제품 라이센스 신청(BLA)을 Leqembi 피하 자가 주사기 (SC-AI)에 대한 주간 유지 요법으로 수용했다고 발표했습니다. PDUFA 예상 날짜는 2025년 8월 31일로 설정되어 있습니다.
Leqembi는 초기 알츠하이머 병 치료를 위해 승인되었으며, 자택에서 사용 가능한 편리한 피하 주사를 제공하는 유일한 FDA 승인 항 아밀로이드 치료제가 될 수 있습니다. SC-AI 360 mg 주간 유지 요법은 격주 정맥 주입 시작 단계 이후에, 15초의 주사 과정을 통해 임상적 이점과 바이오 마커의 이점을 유지하도록 설계되었습니다.
이 치료는 이미 미국, 일본, 중국, 영국에서 승인되었으며, 2024년 11월 EMA로부터 CHMP의 긍정적인 의견을 받았습니다. 이 새로운 전달 방법은 병원 방문을 줄이고 알츠하이머 환자의 치료 경로를 단순화할 수 있습니다.
BioArctic AB a annoncé que la FDA a accepté la demande de licence biologique (BLA) de son partenaire Eisai pour l'autoinjecteur sous-cutané Leqembi (SC-AI) pour une administration hebdomadaire. La date d'action PDUFA est fixée au 31 août 2025.
Leqembi, indiqué pour le traitement précoce de la maladie d'Alzheimer, pourrait devenir la seule thérapie anti-amyloïde approuvée par la FDA à proposer une injection sous-cutanée pratique avec administration à domicile. Le régime de maintien de 360 mg SC-AI par semaine, après la phase d'initiation intraveineuse bimensuelle, est conçu pour maintenir les bénéfices cliniques et des biomarqueurs avec un processus d'injection de 15 secondes.
Ce traitement est déjà approuvé aux États-Unis, au Japon, en Chine, au Royaume-Uni et a reçu un avis positif du CHMP de l'EMA en novembre 2024. Cette nouvelle méthode d'administration pourrait réduire les visites à l'hôpital et simplifier le parcours de traitement pour les patients atteints d'Alzheimer.
BioArctic AB hat bekannt gegeben, dass die FDA den Antrag auf Biologics License Application (BLA) des Partners Eisai für den Leqembi subkutanen Autoinjektor (SC-AI) zur wöchentlichen Erhaltungsdosierung akzeptiert hat. Das PDUFA-Aktionsdatum ist auf den 31. August 2025 festgelegt.
Leqembi, das für die Behandlung der frühen Alzheimer-Krankheit angezeigt ist, könnte die erste von der FDA zugelassene anti-amyloide Therapie werden, die eine bequeme subkutane Injektion mit Selbstverabreichung zu Hause bietet. Das wöchentliche Erhaltungsregime mit 360 mg SC-AI, nach der 14-tägigen intravenösen Einleitungsphase, ist darauf ausgelegt, klinische und biomarkerbezogene Vorteile mit einem 15-Sekunden-Injektionsprozess aufrechtzuerhalten.
Die Behandlung ist bereits in den USA, Japan, China und Großbritannien zugelassen und erhielt im November 2024 eine positive Bewertung des CHMP von der EMA. Diese neue Verabreichungsmethode könnte Krankenhausbesuche reduzieren und den Behandlungsweg für Alzheimer-Patienten vereinfachen.
- Potential to be the only FDA-approved at-home injectable Alzheimer's treatment
- Quick 15-second injection process reduces administration time
- Could reduce healthcare facility visits and associated costs
- Already approved in major markets (US, Japan, China, Great Britain)
- Received positive CHMP opinion for European approval
- FDA approval pending until August 31, 2025
- Requires initial intravenous treatment phase before at-home administration
Insights
The FDA's acceptance of Eisai's BLA for Leqembi's subcutaneous autoinjector represents a pivotal advancement in Alzheimer's disease treatment delivery. The shift from intravenous to subcutaneous administration introduces significant advantages in both clinical practice and market positioning. The proposed 15-second weekly injection dramatically improves the treatment burden compared to current biweekly IV infusions.
The subcutaneous formulation could substantially reduce healthcare system costs by minimizing the need for infusion center visits and professional administration. This development aligns with healthcare's shift toward home-based care models and could expand Leqembi's accessibility to patients who face logistical barriers to regular infusion center visits.
The PDUFA date of August 31, 2025, sets a clear timeline for potential market implementation. If approved, Leqembi would gain a notable competitive advantage as the first and only subcutaneous anti-amyloid therapy for early Alzheimer's disease, potentially strengthening its market position against current and future competitors.
This regulatory milestone could significantly impact BioArctic's market position and valuation. The subcutaneous formulation represents a strategic market expansion opportunity that could drive increased adoption rates and market penetration. With Leqembi already approved in major markets including the US, Japan, China and Great Britain, the subcutaneous delivery system could help capture a larger share of the growing Alzheimer's treatment market.
The home administration capability could be a game-changer for market adoption, potentially leading to higher patient compliance rates and sustained revenue streams. The simplified administration process addresses key barriers in the current treatment paradigm, which could translate to improved commercial performance and market share gains. For investors, this development signals potential revenue growth opportunities and strengthened competitive positioning in the Alzheimer's therapeutic space.
The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI). The injection process is expected to take, on average, 15 seconds. The SC-AI 360 mg weekly maintenance regimen will allow patients who have completed the biweekly intravenous (IV) initiation phase, exact period under discussion with the FDA, to receive weekly doses that are expected to maintain the clinical and biomarker benefits.
The SC-AI is expected to be simple and easy for patients and their care partners to use, and may reduce the need for hospital or infusion site visits and nursing care for IV administration, which will make it easier to continue maintenance administration and may contribute to further simplifying the treatment pathway for AD.
Leqembi is already approved in the US,
The information was released for public disclosure, through the agency of the contact persons below, on January 14, 2025, at 01.00 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
Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions, including the European Union. In November 2024, the treatment received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was accepted by the
Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study 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
Please find full US prescribing information here including Boxed WARNING.
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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