Accelerated Approval Drug For ALS Withdrawn After Failed Phase III Trial

Amylyx Pharmaceuticals is formally withdrawing from the market its accelerated approval drug for amyotrophic lateral sclerosis (ALS), Relyvrio, after a Phase III clinical trial showed it failed to perform better than a placebo, the company announced Thursday (April 4). FDA approved the drug in September 2022, after its advisers initially recommended against approval but then pivoted after Amylyx submitted new analyses the company said confirmed Relyvrio’s effectiveness. But at the time both FDA and the company committed to pull the...