FDA Expected to Grant Full Approval for Biogen and Eisai's Alzheimer’s Drug Leqembi

According to a Bloomberg report on June 30, the U.S. Food and Drug Administration (FDA) is expected to grant traditional approval for Biogen and Japan's Eisai's Alzheimer's drug Leqembi by July 6 (next Thursday). The annual cost of Leqembi without insurance is $26,500; it was initially granted accelerated approval, with Medicare coverage limited to clinical trial use. The Centers for Medicare & Medicaid Services has committed to covering Leqembi under Medicare once the expensive therapy receives full traditional approval, but patients must enroll, providing clinical diagnosis results, among other requirements.