Leqembi's prospects in the Alzheimer's disease market remain uncertain

Following the controversial approval and dismal launch of their first Alzheimer’s drug, Aduhelm (aducanumab), expectations for Eisai (TYO: 4523) and Biogen’s (Nasdaq: BIIB) follow on treatment are mixed, given that their anti-amyloid beta (Aβ) monoclonal antibody (MAb), Leqembi (lecanemab) gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment of Alzheimer’s disease (AD) in patients with early AD.

Achieving full approval will be crucial for Leqembi’s prospects as the US Centers for Medicare and Medicaid Services (CMS) has indicated that full approval of the drug could result in broader coverage, says data and analytics company GlobalData.

Eisai has already submitted a supplemental biologics license application (sBLA) to the FDA seeking the conversion of Leqembi’s accelerated approval to a full approval.