FDA Committee Votes Unanimously To Confirm The Clinical Benefit Of LEQEMBI For Treatment Of Alzheimer’s Disease

The U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously to confirm the clinical benefit of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer’s disease (AD). The committee considered data from the Phase 3 Clarity AD clinical trial sponsored by Eisai Co., Ltd. and Biogen Inc. LEQEMBI has been approved under the FDA accelerated approval pathway. The FDA will take the committee’s confirmation under consideration in making its final decision on LEQEMBI.

The Clarity AD trial met its prespecified primary endpoint . . .