AMX0035 approved as a treatment for ALS in Canada with Conditions

June 13, 2022 – Today, Amylyx Pharmaceuticals, Inc. announced that Health Canada has approved ALBRIOZA (AMX0035) under a Notice of Compliance with Conditions (NOC/c). This means the drug will soon be made available and can be marketed in Canada with certain conditions.

Health Canada’s approval is a positive step forward in the available treatment options for people living with ALS. However, at this stage in the drug access processes, the drug is not yet covered through private or public drug programs. CADTH (and INESSS in Quebec) must complete its review of the therapy and then private, and provincial public drug plans must decide if they will cover the costs associated with the drug.

ALS Canada will continue to be involved in the CADTH Health Technology Assessment process and is actively working to support the pan-Canadian Pharmaceutical Alliance (pCPA) and the provincial drug programs to make informed and expedited reimbursement decisions by bringing forward the perspective and experiences of people affected by ALS. We are hopeful that pan-Canadian and provincial decision-makers in the reimbursement process will work quickly to provide expedited and equitable access for all Canadians who may benefit. There is simply no time to wait for people affected by ALS.

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.

For frequently asked questions about ALBRIOZA (AMX0035) please visit our blog.