03:58 AM EST, 01/27/2025 (MT Newswires) -- Biogen (BIIB) and Eisai said Sunday that the US Food and Drug Administration has approved the supplemental biologics license application for once-every-four-weeks lecanemab-irmb intravenous maintenance dosing for treating early Alzheimer's disease.

The indication for the drug, also known as Leqembi, is for patients with either mild cognitive impairment or mild dementia after 18 months of once-every- two-weeks initiation doses, the companies said.

The application approval is based on analysis of data from a phase 2 study predicting that transitioning to once-every-four-weeks maintenance dosing will maintain the benefits of therapy, the companies said.

"Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer," the companies said.

Eisai pursues the drug's development and regulatory submissions globally while working with Biogen to commercialize and promote it, the companies said.