Amylyx Pharmaceuticals Updated Plans to Advance AMX0035
Amylyx Pharmaceuticals, Inc. provided an update on its plans to advance AMX0035 through the clinical development process for the treatment of amyotrophic lateral sclerosis (ALS).
The company intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021.
And, as previously reported, the company plans to submit a marketing application with Health Canada in Q2 2021.
The FDA has expressed an interest in seeing data from an additional placebo-controlled clinical trial prior to receiving a New Drug Application (NDA) – the vehicle through which a pharmaceutical sponsor formally proposes that the FDA approves an investigational product. To fulfill the FDA’s request and to continue to build upon the growing body of evidence supporting AMX0035 for the potential treatment of ALS, Amylyx plans to initiate a Phase 3 clinical trial in Europe and the United States.