FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
BioArctic AB announced FDA approval for a new maintenance dosing schedule of Leqembi for early Alzheimer's disease treatment. Patients who complete the 18-month biweekly initiation phase can now transition to a once-every-four-weeks 10 mg/kg dosing regimen.
Clinical data demonstrates the importance of continuous treatment, as discontinuation leads to brain amyloid reaccumulation and reversion to placebo-rate decline. Three-year bi-weekly treatment data showed Leqembi reduced cognitive decline by -0.95 compared to a matched natural history cohort, more than double the 18-month result (-0.45).
Leqembi works by clearing amyloid-beta plaque and toxic protofibrils. The drug is already approved in the US, Japan, China, Great Britain, and received CHMP positive opinion for European approval. A subcutaneous autoinjector version is under FDA review with a PDUFA date of August 31, 2025.
BioArctic AB ha annunciato l'approvazione della FDA per un nuovo programma di dosaggio di mantenimento di Leqembi per il trattamento dell'Alzheimer in fase precoce. I pazienti che completano la fase iniziale di 18 mesi con dosaggi bisettimanali possono ora passare a un regime di dosaggio di 10 mg/kg ogni quattro settimane.
I dati clinici dimostrano l'importanza della continuità del trattamento, poiché l'interruzione porta a una nuova accumulazione di amiloide nel cervello e a un declino paragonabile al gruppo placebo. I dati di trattamento bisettimanale di tre anni hanno mostrato che Leqembi ha ridotto il declino cognitivo di -0.95 rispetto a un gruppo di confronto storico, più del doppio del risultato di 18 mesi (-0.45).
Leqembi agisce eliminando le placche di amiloide-beta e i protofibrilli tossici. Il farmaco è già approvato negli Stati Uniti, in Giappone, Cina, Gran Bretagna e ha ricevuto un parere positivo dal CHMP per l'approvazione europea. Una versione con autoiniettore sottocutaneo è attualmente in revisione da parte della FDA, con una data PDUFA del 31 agosto 2025.
BioArctic AB anunció la aprobación de la FDA para un nuevo esquema de dosificación de mantenimiento de Leqembi para el tratamiento de la enfermedad de Alzheimer en fase temprana. Los pacientes que completan la fase de iniciación bi-semanal de 18 meses ahora pueden pasar a un régimen de dosificación de 10 mg/kg una vez cada cuatro semanas.
Los datos clínicos demuestran la importancia del tratamiento continuo, ya que la interrupción lleva a la reacumulación de amiloide en el cerebro y a un retorno a una disminución comparable a la de placebo. Los datos de tratamiento bi-semanal durante tres años mostraron que Leqembi redujo el deterioro cognitivo en -0.95 en comparación con un grupo de historia natural emparejado, más del doble del resultado de 18 meses (-0.45).
Leqembi actúa eliminando las placas de amiloide-beta y los protofibrilos tóxicos. El medicamento ya está aprobado en EE. UU., Japón, China, Gran Bretaña, y recibió una opinión positiva del CHMP para la aprobación europea. Una versión de autoinyector subcutáneo está bajo revisión de la FDA con una fecha PDUFA del 31 de agosto de 2025.
BioArctic AB는 초기 알츠하이머병 치료를 위한 Leqembi의 새로운 유지 용량 일정에 대한 FDA 승인을 발표했습니다. 18개월의 격주 시작 단계를 마친 환자는 이제 4주마다 10 mg/kg 용량으로 전환할 수 있습니다.
임상 데이터는 지속적인 치료의 중요성을 보여주고 있으며, 치료 중단은 뇌의 아밀로이드 재축적과 위약 비율의 감소로 이어집니다. 3년간의 격주 치료 데이터에 따르면, Leqembi는 일치하는 자연 역사 집단에 비해 인지 저하를 -0.95 감소시켰으며, 이는 18개월의 결과(-0.45)의 두 배 이상입니다.
Leqembi는 아밀로이드-베타 플라크와 독성 프로토피브릴을 제거함으로써 작용합니다. 이 약물은 미국, 일본, 중국, 영국에서 이미 승인되었으며, 유럽 승인을 위한 CHMP의 긍정적인 의견을 받았습니다. 피하 자가 주사기 버전은 FDA 검토 중이며, PDUFA 예정일은 2025년 8월 31일입니다.
BioArctic AB a annoncé l'approbation de la FDA pour un nouveau protocole de dosage de maintien de Leqembi pour le traitement de la maladie d'Alzheimer précoce. Les patients ayant complété la phase d'initiation de 18 mois avec des doses bi-hebdomadaires peuvent maintenant passer à un régime de dosage de 10 mg/kg une fois toutes les quatre semaines.
Les données cliniques démontrent l'importance d'un traitement continu, car l'interruption entraîne une nouvelle accumulation d'amyloïde dans le cerveau et un retour à une diminution comparable à celle du groupe placebo. Les données de traitement bi-hebdomadaire sur trois ans ont montré que Leqembi réduisait le déclin cognitif de -0,95 par rapport à un groupe de contrôle d'histoire naturelle apparié, ce qui est plus du double du résultat de 18 mois (-0,45).
Leqembi agit en éliminant les plaques d'amyloïde-bêta et les protofibrilles toxiques. Le médicament est déjà approuvé aux États-Unis, au Japon, en Chine, au Royaume-Uni, et a reçu un avis positif du CHMP pour l'approbation européenne. Une version d'autoinjecteur sous-cutané est actuellement à l'examen par la FDA, avec une date PDUFA fixée au 31 août 2025.
BioArctic AB hat die FDA-Genehmigung für einen neuen Erhaltungsdosierungsplan von Leqembi zur Behandlung der frühen Alzheimer-Krankheit bekannt gegeben. Patienten, die die 18-monatige zweiwöchentliche Einleitungsphase abgeschlossen haben, können nun auf ein Dosisregime von 10 mg/kg einmal alle vier Wochen umstellen.
Klinische Daten zeigen die Bedeutung einer kontinuierlichen Behandlung, da die Unterbrechung zu einer erneuten Ansammlung von Amyloid im Gehirn und zu einem Rückgang auf das Niveau der Placebo-Gruppe führt. Daten zur zweiwöchentlichen Behandlung über drei Jahre zeigten, dass Leqembi den kognitiven Rückgang um -0,95 im Vergleich zu einer angemessenen natürlichen Vergleichsgruppe reduzierte, was mehr als doppelt so viel ist wie das Ergebnis von 18 Monaten (-0,45).
Leqembi wirkt, indem es Amyloid-beta-Plaques und toxische Protofibrillen entfernt. Das Medikament ist bereits in den USA, Japan, China, Großbritannien zugelassen und erhielt eine positive Stellungnahme des CHMP für die europäische Zulassung. Eine subkutane Autoinjektor-Version befindet sich derzeit in der FDA-Prüfung, mit einem PDUFA-Datum vom 31. August 2025.
- FDA approval for simplified maintenance dosing schedule (once every 4 weeks)
- Three-year treatment data shows doubled efficacy (-0.95) compared to 18-month results (-0.45)
- Multiple market approvals secured (US, Japan, China, Great Britain)
- Pending European approval with positive CHMP opinion
- Subcutaneous autoinjector version under FDA review
- Treatment discontinuation leads to disease progression and biomarker deterioration
- Requires 18-month biweekly initiation phase before maintenance dosing
Insights
The FDA's approval of Leqembi's maintenance dosing regimen marks a pivotal advancement in Alzheimer's disease treatment. The new dosing protocol allows for a transition to monthly administration after 18 months of biweekly treatment, representing a significant improvement in the treatment paradigm.
The clinical data is particularly compelling: The three-year treatment data showing a
Key strategic implications include:
- The simplified maintenance dosing could significantly improve patient adherence and reduce healthcare resource utilization
- Global expansion is progressing rapidly with approvals in major markets (US, Japan, China, UK) and pending applications in 17 countries
- The upcoming decision on subcutaneous administration (PDUFA: August 31, 2025) could further enhance the competitive position
- Nordic region commercialization rights provide BioArctic with direct market exposure
The demonstrated necessity of continuous treatment, evidenced by biomarker reversion upon discontinuation, establishes Leqembi as a long-term therapeutic option. This positions the drug favorably for sustained market presence and recurring revenue generation.
Eisai has previously published data supporting the importance of continued ongoing treatment. Data from the off-treatment period between the Phase 2 core study and its long-term extension (LTE) showed that discontinuation of treatment is associated with reaccumulation of brain amyloid, and plasma and CSF biomarkers, and reversion to placebo rate of clinical decline.[1] In addition, recent data of three years of bi-weekly treatment across the Phase 3 Clarity AD core study and LTE, showed that Leqembi reduced cognitive decline on the CDR-SB by -0.95 relative to a matched natural history cohort – more than double the mean change from baseline relative to placebo on the CDR-SB at 18 months (-0.45) – showing expanded clinical and personally meaningful benefit for early AD patients.[2]
Alzheimer's disease is caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal. Continuous administration of Leqembi is of great value to patients as Leqembi works to fight Alzheimer's Disease in two ways: not only rapidly clearing the amyloid-beta (Aβ) plaque, but it also works to fight the progressive nature of Alzheimer's disease by continuously clearing the highly toxic protofibrils that otherwise continue to cause neuronal injury.
The sBLA for the once every 4-week dosing regimen is based on modeling of observed data from the Phase 2 study and its long-term extension (LTE) as well as the Clarity AD study and its LTE study. Modeling simulations predict that transitioning to once every 4 weeks maintenance dosing after 18 months of biweekly treatment will maintain clinical and biomarker benefits of therapy.
Leqembi is already approved in the US,
Leqembi 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 jointly commercialize Leqembi 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 is obliged to make public pursuant to the Financial Instruments Trading Act. The information was released for public disclosure, through the agency of the contact persons below, on January 27, 2025, at 00:30 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. In January 2025, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous auto injection formulation, which is being developed to enhance convenience for patients, was accepted in 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 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] Eisai presents long-term administration data of lecanemab at the Alzheimer's Association International Conference (AAIC) 2024. Available at: https://www.eisai.co.jp/ir/library/presentations/pdf/4523_240731_1.pdf
[2] A change from 0.5 to 1 on the CDR score domains of Memory, Community Affairs and Home/Hobbies is the difference between slight impairment and loss of independence, such as people's ability to be left alone, remember recent events, participate in daily activities, complete household chores, function independently and engage in hobbies and intellectual interests.
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