Ionis Pharmaceuticals (IONS) moves closer to broader European Tryngolza use
CHMP support advances an expansion into severe hypertriglyceridaemia, with a final Commission decision still pending.
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Ionis announced a positive CHMP opinion for Tryngolza in adults with severe hypertriglyceridaemia and fasting triglycerides of at least 880 mg/dL. The proposed European use is alongside diet and other lipid-lowering treatments.
The recommendation rests on the Phase 3 CORE and CORE2 studies. A pooled analysis showed an 85% reduction in adjudicated acute pancreatitis events over 12 months compared with placebo, according to the announcement. The clinical argument therefore extends beyond lowering a laboratory measure to reducing a serious complication.
A final European Commission decision is expected in the fourth quarter. The opinion itself is not that decision, and the proposed European threshold should not be replaced with the broader US indication when estimating the eligible population.
Commercial responsibilities also differ by territory. Ionis markets the medicine in the United States, while Sobi holds rights outside the US excluding Canada and China. A European expansion could broaden the product’s reach, but country-level access and reimbursement will shape the conversion of regulatory progress into sales.