
Amylyx Pharmaceuticals, Inc. has received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Marketing Authorisation Application (MAA) of AMX0035 (ALBRIOZA®) in the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). This decision follows a formal re-examination process. While AMX0035 has been approved in Canada and the U.S., its European approval remains uncertain. Amylyx is committed to exploring all avenues to bring the treatment to the EU, with Phase 3 trial results expected in mid-2024 and a final decision from the European Commission anticipated by the end of 2023.
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