The US Food and Drug Administration strongly backed Eisai Co., Ltd.’s conclusion that a Phase III study of Leqembi (lecanemab-irmb) demonstrated the clinical benefit of the drug for treatment of Alzheimer’s disease and a six-member advisory committee agreed. But there is some debate in the medical community as to whether a half of a point difference on a cognition scale, or a five month delay in decline, is clinically meaningful.
The members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had no reservations about the drug’s clinical efficacy....
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