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Amylyx May Pull FDA-Approved ALS Drug After Failed Phase 3 Trial

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Topline results for the ALS drug Relyvrio show that it failed to meet primary or secondary endpoints. The company says it may voluntarily pull the drug from the market.

-taurursodiol offered no significant improvements compared to placebo, failing to meet the randomized controlled trial's primary or secondary endpoints, Amylyx Pharmaceuticals announced in a statement.

Those findings, along with testimony submitted by more than 1300 ALS patients, advocates, and clinicians, were enough to sway the advisory panel to reverse its earlier decision.

 

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