Biotechnology company Ionis Pharmaceuticals Inc (Nasdaq:IONS) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of TRYNGOLZA (olezarsen) for adults with severe hypertriglyceridemia (sHTG) and fasting triglyceride levels of at least 880 mg/dL.

The European Commission is expected to make a final decision in the fourth quarter of 2026.

If approved, TRYNGOLZA would become the first and only RNA-targeted therapy authorised in the European Union for this patient population. The recommendation follows US approval for sHTG in June 2026.

The CHMP recommendation is based on Phase 3 CORE and CORE2 trial results, which showed placebo-adjusted mean triglyceride reductions of up to 72% at six months, sustained through 12 months. A pooled analysis also found an 85% reduction in adjudicated acute pancreatitis events over 12 months compared with placebo, with a favourable safety and tolerability profile.

Ionis discovered and developed TRYNGOLZA and commercialises it in the United States, while Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI) holds exclusive commercialisation rights outside the US, excluding Canada and China, under a licensing agreement. The companies are working toward potential EU approval for a treatment intended to help reduce the risk of acute pancreatitis in patients with sHTG.