Arrowhead Pharmaceuticals has received authorisation from Health Canada for its small interfering RNA (siRNA) medicine, Redemplo (plozasiran), as an adjunct to diet for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS) who have not responded to standard therapies.
The approval provides a new treatment option for this rare condition, which is linked to extremely elevated triglyceride levels and an increased risk of acute, recurrent pancreatitis.
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Redemplo is said to be the first siRNA medicine approved by Health Canada for FCS and can be self-administered at home via subcutaneous injection every three months. This authorisation follows recent US approval.
The therapy’s approval was based on data from the Phase III PALISADE study, a placebo-controlled, randomised, double-blind trial involving adults with genetically or clinically confirmed FCS, at 39 sites globally, including five in Canada.
Arrowhead Pharmaceuticals president and CEO Christopher Anzalone said: “We are thrilled to start the new year with Health Canada’s approval of Redemplo as a new treatment option for Canadians living with genetic or clinical FCS.
“Arrowhead continues to drive RNAi innovation with our TRiM platform, which is now capable of delivering siRNA to multiple cell types throughout the body and potentially treat a growing array of diseases. As we expand our commercial capabilities, we aim to bring these new treatments to the patients who need them.”
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By GlobalDataResults from PALISADE were presented at the European Society of Cardiology (ESC) Congress 2024 and American Heart Association Scientific Sessions 2024, with simultaneous publication in The New England Journal of Medicine and Circulation.
Redemplo has received orphan drug, breakthrough therapy, and fast track designations from the US Food and Drug Administration (FDA) and orphan medicinal product designation from the European Medicines Agency (EMA) for FCS.
In November 2025, Arrowhead Pharmaceuticals achieved its first successful commercial target after the FDA approved its siRNA medicine to treat FCS.
