Ionis gains EU recommendation for 880 mg/dL triglyceride indication
- Ionis Pharmaceuticals announced a positive European regulatory recommendation to extend TRYNGOLZA's indication to adults with severe hypertriglyceridemia and fasting triglycerides of at least 880 mg/dL.
- The company's Phase 3 trials reported triglyceride reductions of up to 72% and an 85% reduction in acute pancreatitis events compared with placebo.
- Ionis expects a final European Commission decision in the fourth quarter of 2026, with Sobi holding the relevant European commercialization rights.
Ionis Pharmaceuticals (NASDAQ:IONS) announced that European regulators recommended expanding TRYNGOLZA's indication to adults with severe hypertriglyceridemia and fasting triglycerides of at least 880 mg/dL.
The recommendation follows TRYNGOLZA's June 2026 U.S. approval for adults with triglycerides of at least 500 mg/dL and its existing European authorization for familial chylomicronemia syndrome.
"Following TRYNGOLZA’s approval for sHTG in the U.S. in June, today’s positive CHMP opinion marks an important step towards making this treatment available to patients with sHTG in the EU," said Ionis CEO Brett P. Monia.
Ionis reported that its CORE and CORE2 trials showed placebo-adjusted triglyceride reductions of up to 72% after six months and an 85% reduction in adjudicated acute pancreatitis events over 12 months.
Ionis expects the European Commission to decide on the indication extension during the fourth quarter of 2026, while its shares closed at $44.12 on October 15 before any confirmed post-announcement price reaction.
Ionis developed TRYNGOLZA and markets it in the United States, while Swedish pharmaceutical company Sobi holds exclusive commercialization rights outside the United States, Canada and China.
The companies previously secured European approval for TRYNGOLZA in familial chylomicronemia syndrome in September 2025, followed by the broader U.S. severe hypertriglyceridemia approval in June 2026.
