Health Canada authorizes first siRNA therapy for rare Lipid Disorder

On January 6, 2026, Health Canada granted authorization to Arrowhead Pharmaceuticals for Redemplo (plozasiran). This milestone marks the first small interfering RNA (siRNA) medicine approved in Canada for adults living with familial chylomicronemia syndrome (FCS).

Treatment profile and administration Redemplo is authorized as an adjunct to diet to reduce triglycerides in patients who have not achieved adequate results with standard therapies.

  • Mechanism: The therapy utilizes siRNA technology to target and reduce the production of proteins responsible for extreme triglyceride elevation.

  • Convenience: The medicine is designed for self-administration via subcutaneous injection once every three months, allowing patients to manage their condition from home.

Clinical foundation The authorization was supported by data from the Phase III PALISADE study. This global, double-blind trial demonstrated the therapy’s efficacy in lowering lipid levels and mitigating the risk of acute, recurrent pancreatitis—a life-threatening complication associated with FCS.

Market expansion This approval follows the drug’s initial commercial success in the United States in late 2025. Redemplo has previously received orphan drug and breakthrough therapy designations from the U.S. FDA and the European Medicines Agency (EMA), highlighting its significance as a new intervention for this high-risk patient population.

Source: https://www.worldpharmaceuticals.net/news/arrowhead-receives-health-canada-authorisation-for-redemplo-to-treat-fcs/

0 0 votes
Article Rating
Subscribe
Notify of
0 Comments
Oldest
Newest Most Voted
Inline Feedbacks
View all comments