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A few days ago, Amylyx Pharmaceuticals announced that it has submitted a New Drug Application (NDA) for AMX0035 to the US FDA for the treatment of amyotrophic lateral sclerosis (ALS)
This NDA submission is based on the positive data obtained from a phase 2 clinical trial.
In addition, a 3-year follow-up of all randomized subjects showed that patients who were treated with AMX0035 at the beginning of the trial had a risk of death compared with patients who were initially treated with placebo and switched to AMX0035 during the open-label phase.
Amylyx also plans to submit a marketing authorization application (MAA) for AMX0035 to the European Medicines Agency (EMA) at about the end of 2021, and to initiate a global phase 3 clinical trial in the fourth quarter of 2021, with approximately 600 subjects To evaluate the safety and efficacy of AMX0035
Reference materials:
[1] Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS.
