Amylyx ALS Drug Fails in Follow-Up Trial, Raising Questions About Controversial FDA Approval
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Amylyx Pharmaceuticals' ALS drug Relyvrio failed to help patients in a large follow-up study after being approved by the FDA in 2022 based on questionable data.
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The company said it would discuss plans with patients and the FDA, which "may include voluntarily withdrawing" the drug from the market.
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Relyvrio was approved despite concerns from FDA scientists and an outside committee initially voting against it.
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Amylyx had committed to pull the drug if larger follow-up studies didn't confirm it helps ALS patients.
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Shares of Amylyx Pharmaceuticals plunged over 80% on Friday after the negative study results for its much-debated ALS drug.