Biogen (BIIB) and Japanese partner Eisai announced that the FDA has accepted Eisai’s supplemental biologics license application (sBLA) seeking approval for a maintenance intravenous (“IV”) dosing version of Leqembi for the treatment of early Alzheimer’s disease. The FDA is expected to give its decision on the sBLA on Jan 25, 2025. Leqembi was approved as an injection for intravenous use by the FDA for early Alzheimer’s disease in the United States in July 2023. Leqembi is also approved in China and Japan. R ...