WASHINGTON (AP) — The maker of a much-debated drug for Lou Gehrig’s disease said Friday its therapy failed to help patients in a large follow-up study, but stopped short of committing to follow through on a prior pledge to pull the drug from the U.S. market. The Food and Drug Administration approved Amylyx Pharmaceuticals’ Relyvrio in September 2022, following a years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or ALS, a fatal muscle-wasting disease. Amylyx said Friday in a statement it will discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug.
Maker of much-debated ALS drug says it may stop selling it after study showed it didn't work