Posted by Michael Wonder on 14 Oct 2023
Amylyx Pharmaceuticals receives negative CHMP opinion on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union following re-examination process
13 October 2023 - Final decision from the European Commission expected by the end of 2023.
Amylyx Pharmaceuticals today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its initial negative opinion on the Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name ALBRIOZA®, for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU).
