Relyvrio reduces inflammatory biomarkers in ALS: CENTAUR data

Treatment with Relyvrio (sodium phenylbutyrate and taurursodiol) significantly reduced blood levels of neuroinflammatory biomarkers in people with amyotrophic lateral sclerosis (ALS) as early as three months, according to a post hoc analysis of the CENTAUR trial. Data from the Phase 2 study (NCT03127514) demonstrated that reductions in…

FDA Panel Reconvenes in September to Discuss AMX0035 Approval

A U.S. Food and Drug Administration (FDA) advisory committee will meet  Sept. 7 to discuss the approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS), Amylyx Pharmaceuticals announced. While the application was granted priority review earlier this year, with a final decision expected by June…

Health Canada to Review AMX0035 as ALS Treatment

Health Canada has agreed to review Amylyx Pharmaceuticals‘ application seeking approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). “We are pleased that our submission has been accepted for review by Health Canada, and we are committed to serving those affected by ALS in the…