Amylyx, the maker of the ALS drug Relyvrio, is pulling the drug from the market and laying off 70% of its workforce after a large clinical trial showed the drug did not help patients. The drug, approved by the FDA in September 2022, failed to meet its goals in a 48-week trial involving 664 patients, leading to its withdrawal from the market. Patients already taking the medication can continue through a free drug program, but it is no longer available to new patients. Amylyx is now focusing on other drug candidates for neurodegenerative diseases and will lay off most of its employees.
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.
Amylyx's FDA-approved ALS drug, Relyvrio, has failed a crucial Phase III trial, prompting the company to consider withdrawing the drug. In a study of 664 ALS patients, the drug did not outperform a placebo and missed all secondary outcomes, including quality-of-life assessments and muscle function. The failure puts access to the drug in jeopardy and is a significant setback for the treatment of the neurodegenerative disease.
