Amylyx Pulls ALS Drug From Market After Reviewing Negative Topline Data

Following through on a 2023 pledge from its CEO, Amylyx is voluntarily pulling its controversial amyotrophic lateral sclerosis drug Relyvrio/Albrioza (AMX0035; ursodoxicoltaurine) after the drug failed its confirmatory phase 3 study.

While Relyvrio will be removed from both the U.S. and Canadian markets, Amylyx will continue to make it available at no charge to current patients who believe they’re benefitting from it, the company said. Amylyx continues to advance AMX0035 in Wolfram syndrome and in progressive supranuclear palsy (PSP).

The primary outcomes for the phase 3 study, PHOENIX, were changes in the slope of decline as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), plus adverse events and drug discontinuations. Secondary outcomes were decreases in respiratory capacity; quality of life; time free of ventilation; overall health status; and long-term survival. However, the company said it won’t release any details until its April 16 presentation at the American Academy of Neurology Annual Meeting in Denver.

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