FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease

(RTTNews) - Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the Supplemental Biologics License Application (sBLA) for lecanemab-irmb, marketed as LEQEMBI in the U.S., to be administered once every four weeks.

LEQEMBI is prescribed for Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or in the early dementia stage of the disease, collectively known as early AD, in the U.S. After an initial treatment phase lasting 18 months, during which the drug is administered once every two weeks, patients may transition to a maintenance dosing regimen of 10 mg/kg every four weeks, or they may continue with the biweekly dosing regimen.

LEQEMBI is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico and Macau. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. Eisai has submitted applications for approval of lecanemab in 17 countries and regions. Additionally, the FDA accepted Eisai's Supplemental Biologics License (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025.

Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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