The FDA on Thursday granted Leqembi, developed and manufactured by Eisai and Biogen, traditional approval – the first Alzheimer’s drug to get the approval in more than two decades.
Leqembi, which moderately slowed trial participants’ cognitive decline but had potentially serious side effects, including brain swelling and bleeding, was previously granted accelerated approval.
The drug’s costs of more than $26,000 annually will be reimbursed by Medicare, but only for beneficiaries in the nationwide registry that tracks side effects and outcomes in patients over time.
That raises the question of how many people will actually get access to the drug targeted at patients in the early stages of the debilitating disease, so lawmakers and advocacy groups are pressing the Centers for Medicare and Medicaid Services (CMS) to ensure maximum patient uptake by reducing or eliminating coverage restrictions for Leqembi.
Last June, after FDA issued Aduhelm conditional approval with the requirement that further trials show it’s safe and it slows cognitive decline, but CMS decided to only cover Biogen’s controversial Alzheimer’s drug for patients enrolled in randomized clinical trials.