BRIEF—Amylyx to submit NDA for ALS drug

US biotech Amylyx Pharmaceuticals is to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate/taurursodiol) for the treatment of amyotrophic lateral sclerosis (ALS) within months.

US biotech Amylyx Pharmaceuticals is to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate/taurursodiol) for the treatment of amyotrophic lateral sclerosis (ALS) within months.The decision follows recent discussions with the FDA, including a pre-NDA meeting held on July 15, 2021.

A filing has also been submitted to Health Canada and another is on its way to the European Medicines Agency, with a global Phase III trial with sites in Europe and the USA due to begin imminently.