The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has voted 6-0 in favor of granting full approval to Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. The decision is expected to result in full FDA approval on or before July 6th, as the agency usually follows its advisory committees' recommendations. The FDA released briefing documents that showed agency staff believed the trial, dubbed Study 301 (CLARITY AD), verified the clinical benefit of lecanemab for treating AD. Centers for Medicare & Medicaid Services are ready to provide coverage for anyone with Medicare Part B who meets the criteria upon traditional FDA approval. This marks a significant step forward in Alzheimer's treatment, as Leqembi would become only the third drug approved by the FDA to treat Alzheimer's disease.
Keywords: FDA, Eisai, Biogen, Leqembi, Alzheimer's disease
The unanimous support from the adcomm signals a positive outlook for those suffering from Alzheimer's disease. The decision comes after much anticipation and speculation about whether or not Leqembi would receive full approval from the FDA. With CMS indicating their readiness to provide coverage for patients with Medicare Part B who meet certain criteria upon traditional FDA