A phase 3 study of Amylyx Pharmaceuticals' approved therapy for amyotrophic lateral sclerosis, Relyvrio, failed to find significant efficacy results. By mid-June, the drugmaker might withdraw the drug.
A 48-week study involving 644 ALS patients found the drug to be safe and well-tolerated, but the clinical trial did not reach primary or secondary endpoints to prove efficacy, the Cambridge, Mass.-based drugmaker said March 8.
For the next eight weeks, Amylyx said it will communicate with regulatory agencies, experts and the ALS community about whether to remove the treatment from the market. The drugmaker is voluntarily halting promotion of Relyvrio, which the FDA approved in September 2022.