Leqembi’s benefit is clear. Safe use in real world is murkier, FDA panel says

The advisory committee meeting on Eisai’s Alzheimer’s therapy showcased the gulf between the data and monitoring tools available today, and what’s needed to understand which patients should receive the therapy, and who should avoid it.

As expected, Leqembi lecanemab sailed through the panel’s efficacy discussion and vote, further clearing what already appeared to be a smooth path to full approval. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-0 in favor of the conclusion that the results of the Phase III Clarity AD trial support conversion of the drug’s accelerated approval to full approval. Eisai Co. Ltd. (Tokyo:4523) is looking forward to a July 6 PDUFA date for the therapy, as is partner  Biogen Inc. (NASDAQ:BIIB), which has a 50-50 cost and profit-sharing agreement with Eisai...