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 will request a formal re-examination procedure of the current Marketing Authorisation Application. AMX0035 is being explored as a potential treatment for other neurodegenerative diseases.
Amylyx Pharmaceuticals has announced that it will seek re-examination of its Conditional Marketing Authorisation Application with CHMP after receiving a negative opinion on its drug AMX0035. This decision follows the company's May 2023 announcement that CHMP was trending toward a negative opinion. The drug is used to treat amyotrophic lateral sclerosis (ALS) in adults and is known by the trade name ALBRIOZA.
The CENTAUR trial was funded, in part, by the ALS ACT grant and the