FDA adcomm recommends Alzheimer’s drug Leqembi for full approval

Leqembi

Looking forward, the FDA’s Prescription Drug User Fee Act date for Leqembi is July 6.

External advisors to the Food and Drug Administration unanimously recommended Leqembi, the Alzheimer’s drug jointly developed by Biogen and Eisai, for full approval Friday afternoon.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee reviewed Leqembi’s supplemental Biologics License Application and encouraged the agency to greenlight the drug on July 6, its Prescription Drug User Fee Act date.

The Nasdaq halted trading of Biogen’s stock Friday morning ahead of the vote.

The decision was hardly a surprise following the FDA signalling earlier this week that Leqembi is likely to receive full approval next month following a confirmatory trial indicating clinical benefit.