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Eisai/Biogen’s Leqembi Will See Broadened Access To Majority Of Patients

Full Approval For Alzheimer’s Triggers CMS Coverage

 
• By Mandy Jackson

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.

Geriatric doctor consults with Alzheimer's patient
Leqembi's updated label has new language for prescribers on safety • Source: Shutterstock

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...

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