03:48 AM EST, 01/14/2025 (MT Newswires) -- Biogen (BIIB) and Eisai said late Monday the US Food and Drug Administration has accepted Eisai's biologics license application for lecanemab-irmb subcutaneous autoinjector for weekly maintenance dosing in the treatment of patients with early Alzheimer's disease.

The drug, known commercially as Leqembi, is indicated specifically for the treatment of Alzheimer's in patients with mild cognitive impairment or mild dementia, the companies said.

A prescription drug user fee act action date has been set for Aug. 31, the companies said.

Eisai leads the development and regulatory submissions for Leqembi while working with Biogen to commercialize and promote it.