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FDA Accepts Eisai’s Biologics License Application for LEQEMBI® Subcutaneous Autoinjector for Alzheimer’s Disease

NextEdge Admin

15 Jan 2025

2 min 49 sec

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. FDA has accepted Eisai’s Biologics License Application (BLA) for LEQEMBI® (lecanemab-irmb) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for treating Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia (early AD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for August 31, 2025.

The BLA submission is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved, LEQEMBI SC-AI would be the only at-home subcutaneous treatment for AD, administered via a 15-second autoinjector process. Patients completing the biweekly intravenous (IV) initiation phase would transition to weekly subcutaneous doses, maintaining clinical and biomarker benefits.

AD is a progressive disease driven by neurotoxic processes before and after amyloid-beta (Aβ) plaque deposition. LEQEMBI fights AD by clearing both protofibrils and plaques. Protofibrils, the most toxic Aβ form, contribute to neuronal damage and cognitive decline. Long-term three-year LEQEMBI data from the 2024 Alzheimer’s Association International Conference suggest early, continuous treatment may extend therapeutic benefits beyond plaque clearance.

The SC-AI offers a more convenient alternative to IV infusions, potentially reducing hospital visits and simplifying treatment. LEQEMBI is currently approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico, and Macau, with regulatory applications submitted in 17 other regions. The FDA also accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly IV maintenance dosing, with a PDUFA date of January 25, 2025. Eisai leads lecanemab’s development and regulatory submissions, co-commercializing it with Biogen.

LEQEMBI® is indicated for AD treatment in patients with MCI or mild dementia, consistent with its clinical trial population.