Highlights:

  • On October 4, Health Canada approved Radicava (edaravone) for the treatment of ALS.
  • Health Canada’s terminology for this approval is called a Notice of Compliance, or NOC. The approval follows a 180-day priority review of the drug.
  • Approval from Health Canada means that Radicava (edaravone) can be marketed and sold in Canada. Other considerations, like the price of the drug and whether it will be covered through provincial drug plans, have not yet been determined and are separate steps in how drugs become approved and available to Canadians.

What happens next? 

CADTH (the Canadian Agency for Drugs and Technologies in Health) and INESSS in Quebec have already begun their economic analysis of Radicava (edaravone), which informs their recommendation to provincial and territorial drug plans as to whether the drug costs should be publicly covered. In partnership with provincial ALS Societies, ALS Canada provided input on behalf of the ALS community that is also part of CADTH’s review process.

We hope to see a positive reimbursement recommendation and will work with ALS Societies across Canada to advocate for approved ALS therapies to be listed on provincial formularies for coverage at no cost.

Why is the approval of Radicava (edaravone) important?

Health Canada’s approval of Radicava (edaravone) is an important and hopeful milestone for the ALS community. Radicava (edaravone) is only the second ALS therapy to be approved by Health Canada and the first in nearly 20 years. It is our hope that the approval of Radicava (edaravone) will build momentum for the development of additional therapies, underscoring the importance of research investment.

As we move forward, we will continue to work with ALS Societies across Canada to voice the need for Canadians living with ALS to have timely and equitable access to treatments within the healthcare system.

More information

Canadians living with ALS who are interested in learning more about Radicava (edaravone) should connect with a neurologist at their ALS clinic.

Posted in: Advocacy