The FDA has scheduled a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee Meeting on 9 June 2023 to discuss full approval of Eisai Co and Biogen’s LEQEMBI™ (lecanemab) for the treatment of Alzheimer’s.
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).