A physicians group is urging the Food and Drug Administration to hold an expert panel meeting to review an experimental Alzheimer’s treatment before issuing a full-blown approval, a move that reflects nagging safety issues surrounding the medication.
The appeal follows a step announced last week by the FDA to grant accelerated approval for the medicine, which is called Leqembi. Accelerated approval is a faster path to the marketplace based on preliminary clinical trial evidence. The companies behind the drug – Eisai and Biogen – are expected to provide still more data shortly so the FDA can consider a final approval decision.
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