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U.S. FDA panel votes against Amylyx’s ALS drug over trial data concerns


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Reuters - 31/03/2022 - A panel of outside advisers to the U.S. Food and Drug Administration on Wednesday voted against approving Amylyx Pharmaceuticals Inc's drug for amyotrophic lateral sclerosis (ALS).  The committee voted 6 to 4 against the oral drug, AMX0035, saying the company's clinical study data failed to establish it was effective.  Amylyx's FDA submission was based on a 24-week placebo-controlled study of 137 participants with ALS.  Amylyx, in response to FDA's decision, said it is confident in the trial ...


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