"FDA-Approved ALS Drug Relyvrio Withdrawal Looms After Amylyx's AMX0035 Fails Global Phase 3 Trial"
TL;DR Summary
Despite the FDA's reluctance to pull fully-approved drugs from the market, the significant failure of Amylyx's Phase III data in ALS, with a failed primary endpoint and missed secondary endpoints, may leave the company with few options, especially considering past promises to consider withdrawing the drug if the final-stage study didn't succeed.
- FDA precedent won’t help Amylyx as experts point to clarity of PhIII failure in ALS Endpoints News
- A.L.S. Drug Relyvrio Fails Clinical Trial and May Be Withdrawn From the Market The New York Times
- Amylyx ALS drug fails large clinical trial - STAT STAT
- FDA-approved ALS drug Relyvrio could be pulled from market after failing clinical trial USA TODAY
- Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS Business Wire
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