Eisai Co., Ltd. and its partner Biogen, Inc. can proceed with the full commercial launch of Leqembi (lecanemab) now that the Alzheimer’s drug has received full approval from the US Food and Drug Administration, and since the Centers for Medicare and Medicaid Services (CMS) confirmed a commitment it made in June to provide Medicare coverage for anti-amyloid therapies granted full approval.
The FDA converted Leqembi’s accelerated approval to traditional approval on 6 July, effectively broadening access to the amyloid protofibril-targeting antibody because
