The Food and Drug Administration is convening a meeting of outside experts on Friday to consider full approval for Leqembi, the Alzheimer’s treatment made by Eisai and Biogen.
Leqembi was granted conditional approval in January based on preliminary evidence showing it could eliminate toxic brain plaques from people diagnosed with early-stage Alzheimer’s. At Friday’s meeting, the FDA is asking six independent experts to review a subsequent and larger Phase 3 clinical trial and vote on whether the results confirm Leqembi’s benefit.
The study, published in November, found that Leqembi slowed the rate of cognitive and functional decline by 27% in trial participants compared to a placebo — achieving its primary goal. Brain swelling and small brain bleeds were the most closely watched and concerning side effects attributed to Leqembi.
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