The FDA advisory committee has given unanimous approval for Eisai and Biogen’s Alzheimer’s drug Leqembi to receive traditional approval. However, concerns remain about the safety of the drug in certain subgroups such as people with two copies of the ApoE ε4 allele, a known genetic risk factor in the development of Alzheimer’s disease. The FDA is expected to make a decision on full approval by July 6th. If approved, Leqembi will be the first drug of its class to receive this classification.
Medicare plans to broaden coverage for Alzheimer’s drugs like Leqembi if it receives full FDA approval. However, prescribing physicians must participate in a registry that collects real-world evidence about how Leqembi works which some industry and patient groups believe will limit access.
Although positive news for biopharma partners and Alzheimer's patients, there are still concerns surrounding the safety of Leqembi in certain subgroups such as those requiring concomitant treatment with anticoagulant agents and people with cerebral amyloid angiopathy (CAA). Registry reactions have been mixed with some believing it will provide