On the Cusp of Full Approval, Leqembi’s Rollout Could Face Challenges

Last week, an FDA advisory committee gave Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) its unanimous blessing for traditional approval, signaling it will likely become the first drug of its class to receive this classification. While this is positive news for the biopharma partners and Alzheimer’s patients, concerns linger about the drug’s safety and Medicare coverage.