The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously supported Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease.
This indicates that the FDA is likely to grant full approval before July 6th, as it usually follows its advisory committee's recommendations.
The FDA released briefing documents on Wednesday that showed agency staff believed the trial, dubbed Study 301 (CLARITY AD), verified the clinical benefit of lecanemab for treating AD.
The Centers for Medicare & Medicaid Services has also indicated its intention to broaden coverage for new Alzheimer’s drugs such as Leqembi if they receive full approval from the FDA.
Keywords: FDA, Eisai, Biogen, Leqembi, Alzheimer's disease The US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-0 in support of full approval of Eisai and Biogen’s Leqembi (lecanemab) for treating Alzheimer’s disease. The decision comes after the release of briefing documents by the regulator showing that agency staff believed that a pivotal trial called Study 301 demonstrated “consistently favourable results” for primary and secondary endpoints including a reduction in cognitive decline.