FDA’s Go-Ahead to Amylyx New Drug Application for ALS Drug
Amylyx Pharmaceuticals has announced its plan to submit a New Drug Application (NDA) to the U.S. FDA for its drug, AMX0035 (sodium phenylbutyrate (PB) and Taurursodiol (TURSO)), for the treatment of Amyotrophic lateral sclerosis (ALS).
A few months ago, the company had decided to file for a marketing application to the different regulatory agencies seeking approval on the basis of the Phase II CENTAUR trial, which has shown that the drug showed survival benefit and met its primary endpoints. However, the USFDA had requested for Phase III trial to give its recommendation.
In a recent ...
