Amylyx Pharmaceuticals announced that they have started a process with Health Canada to discontinue the marketing authorization for ALBRIOZA. This means that ALBRIOZA will no longer be available for new patients in Canada. People currently on the therapy in Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program.
ALBRIOZA was approved by Health Canada under the Notice of Compliance with Conditions (NOC/c) pathway in 2022. Amylyx’s decision to remove ALBRIOZA from the market is based on the recent PHOENIX trial results of AMX0035, marketed as ALBRIOZA in Canada and RELYVRIO in the United States, which failed to show an effect on primary and secondary outcome measures.
While we know that this news is disappointing for the ALS community and brings uncertainties, we also hold onto hope for the future. Research into ALS treatments is ongoing, with researchers tirelessly working to uncover new insights and potential treatments. Each advancement brings us one step closer to understanding this complex disease and, ultimately, paving the way for effective treatments that can improve the lives of people affected by ALS.
The ALS Society of Canada remains committed to playing a significant role in the collective effort to drive progress and innovation in ALS research with the vision of a world free of ALS and continue advocating for equitable, timely, and affordable access to approved therapies.
We encourage people living with ALS and their families to consult with their clinicians for guidance during this transition.
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