03:43 AM EDT, 06/10/2024 (MT Newswires) -- Biogen (BIIB) and Eisai said Sunday the US Food and Drug Administration has accepted a supplemental biologics license application for monthly intravenous maintenance dosing of Leqembi for the treatment of early Alzheimer's disease.

Under the proposed treatment plan, patients who have completed the biweekly intravenous initiation phase would receive a monthly dose to sustain removal of protofibrils that damage nerve cells. The application is based on data gleaned from phase 2 and phase 3 studies and their extensions.

The companies said the FDA has set an action date of Jan. 25, 2025, for the drug, also known as lecanemab-irmb.

The companies have partnered on the development and commercialization of Alzheimer's treatments since 2014, with Eisai taking the lead on Leqembi.

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