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FDA Accepts Biologics License Application for Leqembi’s Subcutaneous Autoinjector
On January 13, 2025, BioArctic AB (publ) announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) submitted by its partner, Eisai, for Leqembi in the form of a subcutaneous autoinjector (SC-AI) designed for weekly maintenance dosing. Leqembi is currently approved for use in treating Alzheimer’s disease (AD), specifically targeted at patients experiencing Mild Cognitive Impairment (MCI) or mild dementia, commonly classified as early AD.
Notably, Leqembi stands out as the only FDA-endorsed anti-amyloid therapy that may facilitate subcutaneous injection with an option for at-home administration. The Prescription Drug User Fee Act (PDUFA) has set the action date for the approval decision on this application for August 31, 2025.
The basis for this BLA rests on data from the Clarity AD open-label extension study and modeling of observed outcomes. Should the FDA approve the subcutaneous maintenance dosing for LEQEMBI, it will revolutionize AD treatment by permitting at-home administration via an autoinjector. The injection process is expected to last approximately 15 seconds. The proposed weekly regimen of 360 mg SC-AI is intended for patients who have previously completed the biweekly intravenous (IV) initiation phase, which is currently under discussion with the FDA. This weekly dosing is anticipated to sustain both clinical and biomarker benefits.
This streamlined SC-AI is designed to be user-friendly for patients and their caregivers, reducing the need for hospital visits or nursing support associated with IV administration. By simplifying the maintenance process, this development could significantly ease the treatment journey for individuals affected by Alzheimer’s disease.
Leqembi has already garnered approvals across various markets including the U.S., Japan, China, and Great Britain. In November 2024, it also received a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending its approval.
In addition to the recently accepted BLA, a supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing received FDA acceptance in June 2024, with an expected decision date of January 25, 2025. Furthermore, a rolling submission for the subcutaneous injection formulation is aimed at enhancing patient convenience and is currently under review.
About Leqembi (lecanemab)
Lecanemab, initially developed through a strategic partnership between BioArctic and Eisai, is a humanized IgG1 monoclonal antibody targeting amyloid-beta aggregates in various forms. It has received approvals in multiple countries for treating MCI due to Alzheimer’s disease and mild dementia, with regulatory decisions anchored in robust Phase 3 trial data showing significant results across primary and secondary endpoints. Common adverse events among treated patients include infusion reactions and types of amyloid-related imaging abnormalities (ARIA).
Ongoing and Future Studies
Eisai is actively pursuing regulatory approval for lecanemab in additional regions, including Europe. Currently, a clinical study called AHEAD 3-45 is investigating lecanemab’s effects in individuals with preclinical Alzheimer’s disease. This four-year study, fully recruited as of October 2024, is part of a public-private initiative aimed at further elucidating the drug’s efficacy in early stages of AD. Additionally, a separate clinical study for Dominantly Inherited Alzheimer’s Disease (DIAD) has integrated lecanemab as a core therapy.
About BioArctic and Its Collaborations
Founded in 2005, BioArctic has established long-standing collaborations with Eisai focused on developing treatments for Alzheimer’s disease. The key agreements involve the development and commercialization of lecanemab and its backup antibody. Eisai retains responsibility for clinical development, while BioArctic is facilitating commercial efforts in the Nordic region.
BioArctic AB (publ) is renowned for its commitment to pioneering treatments that halt or reverse neurodegenerative disease progression. The company has a diverse research portfolio aimed at combating various neurological conditions, leveraging proprietary technologies designed to enhance drug delivery across the blood-brain barrier.
For further details on Leqembi and its implications for Alzheimer’s treatment, interested parties are encouraged to review the related regulatory information and research findings available through official channels.
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