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Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.
FDA announced the approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease on Jan. 6, 2023. This move follows recent controversy surrounding the agency’s 2021 approval of another Alzheimer’s disease treatment, Aduhelm (aducanumab), developed by Eisai and BioGen, which was the subject of a congressional report from the House Energy and Commerce Committee and House Committee on Oversight and Reform in late 2022 (1).
Lecanemab-irmb was approved using the Accelerated Approval pathway, which allows FDA to approve drugs for serious conditions with unmet medical need; this can only be done when a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. It also received Fast Track, Priority Review, and Breakthrough Therapy designations.
According to an agency press release, FDA based its approval on results from a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 participants with Alzheimer’s disease, wherein patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, a marker of the disease. FDA is also anticipating results from a Phase III randomized, controlled clinical trial to confirm the drug's clinical benefit.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, director, office of Neuroscience, Center for Drug Evaluation and Research, FDA, in the release. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
1. Belluck, P, Congressional Inquiry into Alzheimer’s Drug Faults Its Maker and FDA The New York Times. Dec. 29, 2022.