European Approval of ALS Drug AMX0035 Faces Review Hurdle

Amylyx Pharmaceuticals faces a second round of questions from the Committee for Medicinal Products for Human Use (CHMP) in its bid to have AMX0035 approved as a treatment for amyotrophic lateral sclerosis (ALS) in Europe. The company will respond to the questions and expects an opinion from the committee by mid-2023. The EMA will consider that opinion in its decision on AMX0035’s potential approval.