The European Medicines Agency recommended expanding Sobi’s TRYNGOLZA to adults with severe hypertriglyceridemia after pooled trial data showed fewer pancreatitis events over 12 months versus placebo.
The agency’s Committee for Medicinal Products for Human Use (CHMP) recommended olezarsen alongside dietary measures and other lipid-lowering medicines for adults with fasting triglycerides of at least 880 mg/dL (10 mmol/L). TRYNGOLZA is already authorized in the EU for adults with genetically confirmed familial chylomicronaemia syndrome. Sobi announced the committee’s opinion Oct. 16.
In the Phase 3 CORE trial, placebo-adjusted triglyceride reductions at six months were 62.9 percentage points with 50 mg and 72.2 points with 80 mg. In CORE2, the corresponding reductions were 49.2 and 54.5 points. Each dose comparison had P<0.001. Across both trials, the acute pancreatitis event rate over 12 months was 85% lower with olezarsen than with placebo; the mean rate ratio was 0.15 (95% confidence interval, 0.05 to 0.40; P<0.001).
The New England Journal of Medicine paper reported similar overall adverse-event rates across trial groups. Liver-enzyme elevations and thrombocytopenia, or low platelet counts, were more common with the 80-mg dose, and liver fat fraction rose with dose.
Guidance issued in 2019 by the European Society of Cardiology and European Atherosclerosis Society identifies triglyceride levels above 880 mg/dL as a point of concern for pancreatitis risk. Sobi estimates about 700,000 people in the EU5 have levels at or above that threshold, citing a 2020 publication. The EMA says olezarsen is designed to reduce the liver’s production of apolipoprotein C-III, a protein involved in triglyceride metabolism.
The U.S. Food and Drug Administration approved TRYNGOLZA for adults with severe hypertriglyceridemia on June 24, 2026, describing it as the first treatment shown to reduce acute pancreatitis risk in that population.
The European Commission must still decide whether to confirm the CHMP recommendation, and the EMA lists its decision as pending. Sobi expects a decision in the fourth quarter of 2026.
