Amylyx Withdraws ALS Drug After Larger Trial Shows Unreliable Benefit; Company Transitions Patients and Refocuses Research
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Amylyx Pharmaceuticals voluntarily removed its ALS drug Relyvrio from the U.S. and Canadian markets after clinical trial showed it doesn't work.
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Relyvrio was approved by FDA in 2022 based on a single trial, but larger trial released last month found its benefit was not reliable.
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Amylyx will slash staff by 70% as it transitions existing patients to a free drug program.
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Voluntarily removing approved drug from market is very rare; expert says Amylyx made the right decision.
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Amylyx will study failed trial results to inform future ALS research and is now focused on developing a drug for Wolfram syndrome.