The U.S. Food and Drug Administration (FDA) converted the approval status of Leqembi (lecanemab-irmb), a treatment for adult patients with Alzheimer's Disease, from accelerated approval to traditional approval.
Leqembi received approval in January through the Accelerated Approval pathway, which allows the FDA to approve drugs for serious conditions with unmet medical needs. As a postmarketing requirement, the FDA required a confirmatory study to validate the anticipated clinical benefit of Leqembi.
Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, stated that this approval marks the first confirmation of a drug targeting the underlying disease process of Alzheimer's disease demonstrating clinical benefit. The confirmatory study established the safety and efficacy of Leqembi as a treatment for patients with Alzheimer's disease.
The approval of Leqembi was granted to Eisai Co (OTC:ESAIY).