80% Triglyceride Reduction Supports UK Approval of REDEMPLO and Funding Recommendation

Key Facts

The UK Medicines and Healthcare products Regulatory Agency granted marketing authorization for REDEMPLO, known scientifically as plozasiran, on 19 October 2026 to Arrowhead Pharmaceuticals Ireland Limited. Arrowhead announced on 27 October that the National Institute for Health and Care Excellence recommended funding the treatment through the National Health Service in England and Wales. The authorization allows its use alongside diet to lower triglycerides in adults with familial chylomicronemia syndrome. The marketing authorization covers the UK, while the funding recommendation formally applies to England and Wales. The decision gives the drug UK authorization and a recommended funding pathway in the UK's two largest constituent countries, according to the company's announcement.

NICE's recommendation defined the group eligible for funding as adults with genetically confirmed disease whose response to diet and conventional triglyceride-lowering treatments is inadequate. The company said the recommendation is subject to a commercial arrangement, without providing details in its announcement. The MHRA authorization covers adults diagnosed through genetic testing or clinical criteria, and allows the drug to be used with diet. The difference in scope means the authorization's terms do not fully match the funding recommendation's conditions in England and Wales. Arrowhead said NHS funding in Scotland is being considered separately, while Northern Ireland requires an additional step to verify the guidance.

The UK authorization was based on the Phase 3 PALISADE study, a placebo-controlled trial involving 75 adults with the syndrome; 50 received plozasiran and 25 received placebo. Participants followed a controlled diet, and the study measured the median change in fasting triglycerides at month 10 compared with placebo. After 10 months, the median reduction in triglycerides was about 80% in the plozasiran group, compared with 17% in the placebo group. The MHRA said trial data showed a substantial reduction in triglycerides when the drug was used alongside a controlled diet. The study also recorded fewer episodes of acute pancreatitis in the treatment group, according to the agency.

Kaushik Ray, professor of public health at Imperial College London and former president of the European Atherosclerosis Society, said PALISADE results showed a significant reduction in median fasting triglycerides at the recommended dose. He noted that the comparison with placebo at month 10 recorded a p-value of less than 0.0001. The MHRA describes plozasiran as limiting production in the liver of apolipoprotein C3, a protein that slows the breakdown of fat. Familial chylomicronemia syndrome causes abnormally high triglyceride levels, which may be associated with pancreatitis and severe abdominal pain. The U.S. Food and Drug Administration approved REDEMPLO on 18 November 2025 as an adjunct to diet to lower triglycerides in adults with the syndrome.

REDEMPLO is administered as a 25 mg subcutaneous injection once every three months, and patients or caregivers can administer it after training. The MHRA said high blood sugar is its most common side effect and may affect more than one person in 10. Other common side effects include headache, nausea and injection-site reactions, which may affect up to one person in 10. In the study supporting U.S. approval, treatment or placebo was given every three months over one year, with the change in triglycerides measured from baseline to month 10. The trial included 75 patients at 54 centers across 20 countries, with 9 participants from centers in the United States.

The drug's regulatory pathway extends into Europe following its UK authorization; the company reported that it is working to make it available in several European countries over the coming months. This follows U.S. Food and Drug Administration approval in 2025, while the company did not specify in its announcement when the drug would become available in European countries. In trading, Arrowhead shares, listed under the ticker ARWR, closed at $58.98 on 26 October 2026, according to EL7 data. The company announced NICE's recommendation the following day, 27 October. The UK recommendation remains limited to NHS funding in England and Wales under its stated conditions.