In an unusual move, the FDA advisory panel convened for the second time in less than a year to review Amylyx's drug for amyotrophic lateral sclerosis.
An advisory committee to the Food and Drug Administration convened Wednesday to review data on an experimental drug for ALS.A Food and Drug Administration advisory panel voted Wednesday to recommend an experimental drug for patients with ALS, a reversal from its decision in March and a victory for advocacy groups pushing for the drug’s approval.
The vote does not mean the drug is now approved; that decision still lies with the FDA, which is expected to make a final rulingThe favorable vote came despite concerns from panel members about whether an additional analysis of a single phase 2 clinical trial, from drugmaker Amylyx Pharmaceuticals, showed clear evidence the drug slows the progression of the disease.
Dr. Kenneth Fischbeck, a neurologist at the National Institutes of Health, said the company's new analysis contained no new data. The FDA has faced pressure from advocacy groups to approve the drug quickly, citing a significant “unmet medical need.” There areapproved by the agency for the disease and its symptoms; one has been shown to extend the lives of patients by about three months.
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