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FDA advisory committee unanimously confirms clinical benefit of LEQEMBI® (lecanemab)

Jun 9, 2023

Biogen announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of LEQEMBI® (lecanemab) for the treatment of Alzheimer’s disease.  The Committee also confirmed the overall benefit-risk profile and the clinical meaningfulness of the data.  The FDA released a briefing document on 7 June 2023 outlining its views ahead of the PCNS meeting on 9 June 2023.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).