Amylyx announces plans to submit a Health Canada application in early 2021

March 9, 2021 – Today Amylyx announced plans to submit a New Drug Submission (NDS) to Health Canada in the first half of 2021 for its AMX0035 therapy. In addition, the company will explore options for early access to AMX0035 in Canada, including a potential special access program (SAP), and aims to finalize plans by the end of the second quarter of 2021.

We know this therapy is of interest to many in the ALS community. And while this announcement does not yet mean the drug is available in Canada, Amylyx’s decision to pursue regulatory approval and a special access program is a promising milestone for the Canadian ALS community.

If Health Canada accepts the NDS application, the next step would be a thorough review, which we hope will be conducted within a six-month priority review. You can read more about Health Canada’s process on their website.

As our community knows all too well, Canadians living with ALS do not have the luxury of time. There is an urgent need for people living with ALS to have access to proven, effective therapies. We hope to see the momentum continue in meaningful ways that will make a difference to Canadians living with the disease.

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 the results of the Phase 2 CENTAUR clinical trial here.