Health Canada Accepts New Drug Submission for AMX0035

August 31, 2021 – Today Amylyx announced that Health Canada has accepted its New Drug Submission (NDS) for AMX0035. This step triggers a thorough regulatory review of the therapy, which will hopefully result in the drug being approved for use in Canada.

We understand that AMX0035 will not receive a six-month priority review. As the ALS community knows well, the process for how drugs become accessible to Canadians takes far too long – and our position is that all ALS therapies should be given Priority Review by Health Canada, which is a six-month process compared to a one-year process. We will be connecting with Health Canada to seek clarification and any further insights.

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