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.
Eisai/Biogen’s Leqembi Will See Broadened Access To Majority Of Patients
Full Approval For Alzheimer’s Triggers CMS Coverage
CMS will cover Leqembi now that the US FDA has converted Leqembi’s accelerated approval to traditional approval, giving most patients eligible for treatment access to the drug. Updated labeling puts greater emphasis on safety concerns.
