FDA Panel Recommends Full Approval For Biogen And Eisai's Alzheimer's Drug Leqembi

(RTTNews) - A panel of independent advisors convened by the U.S. Food and Drug Administration voted to recommend full approval of Biogen (BIIB) and Eisai's (ESALY.PK,ESALF.PK) Alzheimer's disease drug Leqembi.

The companies said that the FDA Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai's Phase 3 Clarity AD clinical trial confirms the clinical benefit of Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer's disease (AD). Additionally, the committee members confirmed the overall benefit-risk profile of Leqembi.

Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta, received accelerated approval on January 6, 2023, and was launched in the U.S. on January 18, 2023.

The Prescription Drug User Fee Act or PDUFA action date for traditional approval of Leqembi has been set for July 6, 2023, with designation of priority review.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

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