The FDA is likely to grant full approval for Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease ahead of an advisory committee vote on the drug. The agency has asked the committee to confirm whether Study 301 results verify lecanemab's clinical benefit, but both the briefing documents and decision will be based on these results. The data from the trial consistently showed favorable results for primary and secondary endpoints, including a reduction in cognitive decline, with safety signals not greater than benefits. Full approval would replace conditional approval granted in January 2023 when questions were raised over Medicare coverage; this was answered last week when CMS announced it would cover new Alzheimer's drugs upon full FDA-approval with physicians required to collect data about patient outcomes.
Five keywords: FDA, Eisai, Biogen, Leqembi (lecanemab), Alzheimer's disease
Leqembi may become fully approved by the FDA after showing consistent positive results in a trial aimed at treating Alzheimer’s disease patients. However, some have criticized that physicians are now required to record information about how well their patients perform using this drug as part of its condition coverage set by Centers for Medicare & Medicaid Services (CMS).