Ionis and Sobi win EU recommendation to expand TRYNGOLZA use
On Oct. 16, 2026, the EMA’s CHMP backed an EU label expansion for Ionis and Sobi’s TRYNGOLZA in adults with severe hypertriglyceridemia. The recommendation covers patients with fasting triglycerides of ≥880 mg/dL, while a final European Commission decision is expected in Q4 2026. Phase 3 results showed up to 72% lower triglycerides and 85% fewer adjudicated pancreatitis events.
Why it matters
The opinion moves TRYNGOLZA closer to EU commercialization for this severe hypertriglyceridemia population, but sales expansion still depends on the European Commission’s decision. Sobi has exclusive commercialization rights outside the U.S., excluding Canada and China, so the outcome has implications for both companies’ European launch plans.
Key facts
- 1On Oct. 16, 2026, the EMA’s CHMP issued a positive opinion supporting an indication extension for TRYNGOLZA in severe hypertriglyceridemia. prnewswire.com
- 2The proposed EU use covers adults with severe hypertriglyceridemia and fasting triglycerides of ≥880 mg/dL [≥10 mmol/L], alongside diet and other lipid-lowering treatments. prnewswire.com
- 3In Phase 3 CORE and CORE2, TRYNGOLZA produced a placebo-adjusted mean triglyceride reduction of up to 72% at six months, sustained through 12 months. prnewswire.com
- 4A pooled analysis found an 85% reduction in adjudicated acute pancreatitis events over 12 months versus placebo. prnewswire.com
- 5The European Commission’s final decision is expected in the fourth quarter of 2026. prnewswire.com
- 6Sobi holds exclusive rights to commercialize TRYNGOLZA outside the U.S., except in Canada and China. prnewswire.com
Summary written by AlphAI AI Desk from 10 of 10 sources. Not investment advice. Figures are as stated by the linked sources.