Amylyx Files New Drug Submission for AMX0035

June 14, 2021 – Today Amylyx announced it has filed a New Drug Submission (NDS) to Health Canada for its ALS therapy AMX0035.

As the ALS community knows well, there is a critical and urgent need for people living with the disease to have equitable, timely and affordable access to proven therapies.  While this announcement does not yet mean Health Canada’s review of the drug has begun, Amylyx’s decision to pursue regulatory approval of AMX0035 is an important step forward. The next step would be Health Canada accepting the company’s NDS, which would trigger regulatory review.

We will continue to post updates as we become aware of them. You can read more in Amylyx’s press release and learn more about how drugs become accessible in Canada by visiting our blog post on this topic.