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.
So far, though, the agency has not indicated whether an advisory committee will be held. The FDA typically convenes such an expert panel to review thorny issues surrounding a medicine. In making its case, Doctors for America maintained that an advisory committee meeting is warranted, given that three patient deaths occurred during clinical testing and were attributed to brain hemorrhages.
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