Posted by Michael Wonder on 28 Feb 2022
Amylyx Pharmaceuticals announces EMA validation of marketing authorisation application for AMX0035 for the treatment of ALS
25 February 2022 - Amylyx Pharmaceuticals today announced that its marketing authorisation application to the EMA CHMP for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [TURSO; also known as taurursodiol]) for the treatment of amyotrophic lateral sclerosis has been validated and is now under CHMP review.
The submission is based on data from the CENTAUR trial, a randomised, double-blind, placebo-controlled Phase 2 clinical trial conducted at 25 centres of the Northeast ALS Consortium (NEALS), evaluating 137 adults with amyotrophic lateral sclerosis.
