Eisai : FDA Accepts SBLA On LEQEMBI For Early Alzheimer's Treatment

(RTTNews) - Eisai Co., Ltd. (ESALY.PK, ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Supplemental Biologics License Application or sBLA for monthly lecanemab-irmb (U.S. brand name: LEQEMBI) intravenous (IV) maintenance dosing.

A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025.

LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA in May 2024.

LEQEMBI is now approved in the U.S., Japan, China and South Korea, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

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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