Biogen, Eisai announce FDA approves Leqembi to treat Alzheimer’s disease

Eisai (ESALY) and Biogen (BIIB) announced that under the Accelerated Approval Pathway the U.S. Food and Drug Administration has approved lecanemab-irmb, brand name in the U.S. Leqembi, 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Abeta) for the treatment of Alzheimer’s disease. The approval is based on Phase 2 data that demonstrated that Leqembi reduced the accumulation of Abeta plaque in the brain, a defining feature of AD. Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application, or sBLA, to the FDA for approval under the traditional pathway. Leqembi will be available during or before the week of January 23. Eisai announced the U.S. pricing and rationale for LEQEMBI today. Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.