Leqembi’s Rollout Could Face Challenges as FDA Advisory Committee Gives Unanimous Blessing for Full Approval

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 Ju..