By Lauren Poplak
Amylyx Pharmaceuticals, Inc announced that Health Canada has approved ALBRIOZA (AMX0035) under a Notice of Compliance with Conditions (NOC/c). This decision came after a nearly 300-day review of the drug’s safety, efficacy and quality and means, with Albrioza approved, the drug is available in Canada with certain conditions.
Health Canada’s approval is a positive step forward in the available treatment options for people living with ALS. And we are very pleased that Canada is the first country to approve ALBRIOZA as a treatment for ALS – demonstrating the strength of the ALS community as an environment for innovative therapies.
However, at this stage in the drug access processes, the drug is not yet covered through private or public drug programs. As a next step, 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.
What is Albrioza?
By Jason Lee
Head of Market Access and Stakeholder Relations
Amylyx Canada Inc.
ALBRIOZA (also known as AMX0035) is an oral fixed-dose combination therapy designed to slow the loss of physical function and may reduce neuronal cell death in people living with ALS, either as a stand-alone therapy or when added to existing treatments. The approval of ALBRIOZA is based on data from CENTAUR, a multicenter Phase 2 clinical trial in 137 participants with ALS.
It is for projects such as this that we hold our annual Walk to End ALS. Forty percent of the proceeds raised goes to the ALS Canada Research Program which invests in the best ALS research in Canada. This is awarded annually following a peer-reviewed competition.
