FDA AdCom votes for in favor of full approval for Leqembi

Having won accelerated approval in January this year, Alzheimer’s drug Leqembi (lecanemab) now looks set to get full approval from the US Food and Drug Administration (FDA) as early as next month.

Leqembi was developed by Japan’s Eisai (TYO: 4523) in partnership with US biotech Biogen (Nasdaq: BIIB), and was launched in the USA on January 18.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on Friday voted unanimously that the data from Eisai’s Phase III Clarity AD clinical trial confirms the clinical benefit of Leqembi 100mg/mL injection for intravenous use for the treatment of Alzheimer’s disease (AD).