The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously voted in support of Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease, indicating that full approval is likely to be granted on or before July 6. The decision was based on clinical trial results showing consistently favorable outcomes for primary and secondary endpoints, including a reduction in cognitive decline. Last week, the Centers for Medicare & Medicaid Services announced its intention to broaden coverage for new Alzheimer's drugs upon traditional FDA approval, such as Leqembi, with physicians required to collect data about how well the drugs perform in their patients. This marks the first time CMS has required physicians to record this kind of information.
Keywords: FDA, Eisai, Biogen, Leqembi, Alzheimer's disease
The FDA is expected to grant full approval for Eisai and Biogen’s Leqembi (lecanemab) following unanimous support from its advisory committee. Clinical trial results showed positive outcomes for primary and secondary endpoints including a reduction in cognitive decline. The Centers for Medicare & Medicaid Services also announced plans to broaden coverage for new Alzheimer’s drugs upon traditional FDA approval but require physicians to collect data about drug performance in patients.