Eisai-Biogen Seek Complete FDA Approval For Its Second Alzheimer’s Treatment

The FDA has accepted Eisai Co Ltd (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection, supporting the conversion of the accelerated approval of Leqembi to a traditional approval.
The Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
The FDA plans to hold an Advisory Committee to discuss this application but has not publicly announced the meeting date.
Also Read: Biogen’s Alzheimer’s Antibody Might Have A Third Death Associated With.
Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of amyloid beta (Aβ).
The FDA approved the treatment under the Accelerated Approval Pathway for Alzheimer’s Disease (AD).
Treatment with Leqembi should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.
Eisai leads Leqembi development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
Price Action: BIIB shares are down 0.43% at $269.11 on the last check Monday.