Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union
Amylyx Pharmaceuticals has received a negative opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on its application for conditional marketing authorisation of AMX0035, under the trade name ALBRIOZA, for the treatment of amyotrophic lateral sclerosis (ALS) in adults. Despite this setback, Amylyx remains confident in its CENTAUR trial data and..