Posted by Michael Wonder on 24 Jun 2023
Amylyx Pharmaceuticals receives CHMP negative opinion on its conditional marketing authorisation application for AMX0035 for the treatment of ALS in the European Union
23 June 2023 - Amylyx will seek re-examination of its conditional marketing authorisation application.
Amylyx Pharmaceuticals today announced that the CHMP of the EMA has adopted a negative opinion on the application for conditional marketing authorisation of AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name Albrioza, for the treatment of adults with amyotrophic lateral sclerosis in the European Union.
