Survival benefit in ALS burnishes Amylyx’s case to regulators

Newly published results from the CENTAUR trial showing an overall survival benefit among ALS patients will add to Amylyx’s data package as it seeks to begin dialogue with FDA about a potential submission of its combination product.

The new data published in Muscle & Nerve showed that after up to 35 months of follow-up, there was a 44% lower risk of death among amyotrophic lateral sclerosis patients who received AMX0035 compared with those who originally received placebo in the 137-patient CENTAUR, regardless of whether they enrolled in the study’s open-label extension (HR=0.56; 95% CI: 0.34, 0.92; p=0.023)...