Health Canada Accepts Supplement to a New Drug Submission and Grants Priority Review for Oral edaravone 

TORONTO, May 13, 2022 – Today, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), announced that Health Canada has accepted its filing of a Supplement to a New Drug Submission (SNDS) for an investigational oral formulation of edaravone. This step triggers a thorough regulatory review of the therapy, which will hopefully result in the drug being approved for use in Canada.

We are also very encouraged to learn that Health Canada has granted a Priority Review, which expedites the review timeline for the therapy to six months.

We believe any new innovative ALS therapy should be granted priority review status – and we are hopeful this decision sets an important precedent for all future ALS therapies. Pathways that advance the pace at which proven therapies become approved and available to Canadians are necessary to address the urgent unmet need of people living with ALS.

You can read more in MTP-CA’s press release and learn more about how drugs become approved and accessible in Canada by visiting our blog post.