04:23 AM EDT, 09/03/2025 (MT Newswires) -- Biogen (BIIB) and Eisai said late Tuesday that Eisai has started the rolling submission of a supplemental biologics license application to the US Food and Drug Administration for subcutaneous lecanemab-irmb, intended to treat early Alzheimer's disease.

The companies said the application is based on data from sub-studies within a phase 3 trial evaluating the subcutaneous formulation across various doses.

If approved, "the autoinjector could be used to administer a once weekly starting dose, as an alternative to bi-weekly intravenous dosing," the companies said.

Eisai is the lead for lecanemab's development and regulatory submissions, while Eisai and Biogen are co-commercializing and co-promoting the product.