ALS drug fails large clinical trial and may be withdrawn from market

Amylyx Pharmaceuticals announced that its ALS drug, Relyvrio, did not show significant benefit in a large clinical trial and may be withdrawn from the market. The phase 3 trial, called Phoenix, did not demonstrate better results than a placebo in improving the ALS functional scale or patient-reported quality of life, overall survival, and respiratory function. Amylyx will engage with regulatory authorities and the ALS community to discuss next steps, including the possible withdrawal of Relyvrio. The nonprofit ALS Association expressed sadness and gratitude to the FDA and Amylyx. ALS affects up to 30,000 people in the US and has no effective treatments. Relyvrio gained FDA approval in September 2022, but controversy surrounded its efficacy assessment.