Last Friday, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted to approve Leqembi, Eisai and Biogen’s Alzheimer’s drug candidate.
In a unanimous vote, members confirmed the overall benefit risk-profile based on results from the global confirmatory phase 3 trial, Clarity AD. Ahead of the meeting, the FDA shared a briefing document outlining its support for Leqembi, stating that the risks identified in confirmatory trials could be detailed in the prescribing information and should not be expected to prevent the traditional approval of the drug.
Leqembi, anti-amyloid beta protofibril antibody, was approved in January under an Accelerated Approval pathway, and the drugmakers announced then that they intended to seek approval under a traditional pathway. The Accelerated Approval was limited to patients in mild stages of cognitive impairment or dementia.
Meanwhile, Eisai has focused on obtaining payer coverage for Leqembi. Back in March, the U.S. Veterans' Health Administration (VHA) said it will provide coverage of the codeveloped anti-amyloid drug for veterans living with early stages of Alzheimer's disease. The news came a month after the Centers for Medicare & Medicaid Services (CMS) rejected a request to provide wider coverage for Leqembi on Medicare, instead applying the same restrictions as it did for Biogen's Alzheimer's drug, Aduhelm.
Then, last week, CMS administrator Chiquita Brooks-LaSure announced that if the FDA grants it traditional approval, then Medicare will cover the drug in appropriate settings. The drug's PDUFA date for traditional approval is July 6, 2023.