05:45 AM EDT, 04/01/2024 (MT Newswires) -- Biogen (BIIB) and Eisai said Sunday that Eisai has submitted a supplemental biologics license application to the US Food and Drug Administration for Leqembi as a monthly lecanemab-irmb intravenous maintenance dosing product.

The companies said Leqembi is currently indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease, or early Alzheimer's disease. According to the partners, the supplemental biologics application was based on data from a phase 2 study and its open-label extension.

Eisai also submitted a request for the FDA's fast track designation for the product's subcutaneous formulation, the companies said. The decision on the designation will be determined within 60 days from the submission, and Eisai plans to initiate a rolling biologics license application for Leqembi once it is granted, the partners added.