The CHMP recommends Tryngolza as an adjunct to diet, in combination with other lipid-lowering therapies, for adults with sHTG and fasting triglyceride levels of 880 mg/dL (10 mmol/L) or higher. If the European Commission confirms the recommendation, Tryngolza would become the first and only RNA-targeted medicine approved in the EU for this patient group. The opinion came earlier than Sobi had expected, and a final decision is anticipated in the fourth quarter of 2026.

The recommendation is based on the pivotal Phase III studies CORE and CORE2. Both were sponsored by Ionis Pharmaceuticals and conducted in collaboration with the TIMI Study Group. In the studies, Tryngolza produced a statistically significant placebo-adjusted mean reduction in fasting triglycerides of up to 72% after six months, and the reduction was sustained over twelve months. A pooled analysis of both studies showed an 85% reduction in confirmed episodes of acute pancreatitis over twelve months compared with placebo. The results were presented at the American Heart Association (AHA) Scientific Sessions 2025 and published in The New England Journal of Medicine.

“The CHMP’s positive opinion reflects the strength of the clinical evidence and brings us one step closer to offering Tryngolza as a new treatment option to reduce the risk of acute pancreatitis in patients with sHTG in the EU,” says Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi. “Acute pancreatitis is a potentially life-threatening complication of sHTG that places a significant burden on patients, with frequent hospitalizations, intensive care, irreversible complications, and reduced quality of life.”

An estimated 700,000 people in the EU5 (France, Germany, Italy, Spain, and the UK) have triglyceride levels of 880 mg/dL (10 mmol/L) or higher. At these levels, the risk of acute pancreatitis rises sharply. Acute pancreatitis often requires intensive care and prolonged hospitalization and can cause permanent organ damage.

Tryngolza was discovered and developed by Ionis, which also commercializes the drug in the US. Under a licensing agreement, Sobi holds exclusive rights to commercialize it outside the US, except in Canada and China.