Health Canada has approved REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), based on Phase 3 PALISADE data. This update highlights what is unique about the Canadian approval and links to our detailed FDA coverage.
Written By: Pharmacally Medical News Desk
Arrowhead Pharmaceuticals has announced that Health Canada has granted approval to REDEMPLO (plozasiran) as an adjunct to diet for the reduction of triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare genetic lipid disorder. This joins the earlier U.S. FDA approval and expands access to this treatment option for eligible patients in Canada.
Key Details of the Canadian Approval
Regulatory authorization: Health Canada issued a Notice of Compliance (NOC) for REDEMPLO (plozasiran) as an adjunct to diet to reduce triglyceride levels in adults with FCS for whom standard triglyceride-lowering therapies have been inadequate.
First siRNA therapy approved in Canada for FCS: REDEMPLO is the first small interfering RNA (siRNA) therapeutic authorized by Health Canada specifically for this condition.
Mechanism of action: The drug works by silencing the liver gene for apolipoprotein C-III (apoC-III), a protein that slows the breakdown of triglyceride-rich lipoproteins. This results in substantial reductions in circulating triglyceride levels.
Based on PALISADE Phase 3 data: Health Canada’s decision was supported by results from the Phase 3 PALISADE study, which met its primary endpoint with a median triglyceride reduction of about 80% versus 17% with placebo the same pivotal trial that underpinned the FDA approval.
Dosing: The therapy is administered as a subcutaneous injection every three months and can be self-administered at home.
This Canadian decision follows the U.S. FDA approval of REDEMPLO in 2025, further expanding access to this siRNA therapy for FCS. For a full overview of REDEMPLO’s FDA approval, Phase 3 PALISADE results, mechanism of action, safety profile, and clinical context, see our detailed article on the U.S. approval of REDEMPLO
Reference
Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLO™ (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS), 05 January 2026, Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLO™ (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) – Arrowhead Pharmaceuticals, Inc.
FDA Approves Redemplo (Plozasiran) to Lower Triglycerides in Adults with Familial Chylomicronemia Syndrome: First siRNA Therapy Offering Hope to Rare Disease Patients, 19 November 2025, https://pharmacally.com/fda-approves-redemplo-plozasiran-to-lower-triglycerides-in-adults-with-familial-chylomicronemia-syndrome-first-sirna-therapy-offering-hope-to-rare-disease-patients/