Sobi Gets EMA Panel Recommendation for Expanded Use of Tryngolza in Severe Hypertriglyceridemia

09:15 AM EDT, 10/16/2026 (MT Newswires) -- Swedish Orphan Biovitrum (SOBI.ST), or Sobi, said a European Medicines Agency committee recommended approving an expanded indication for Tryngolza as treatment for adults with severe hypertriglyceridemia, one of the causes of acute pancreatitis. The Committee for Medicinal Products for Human Use's recommendation for Tryngolza, or olezarsen, is based on results from the pivotal phase 3 Core and Core2 studies, which met their primary endpoint, according to a Friday release. In the trials, Tryngolza showed a statistically significant placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, an effect sustained through 12 months. The European Commission is expected to issue its final decision in the fourth quarter. Once approved, Tryngolza would become the first and only RNA-targeted therapy authorized in the European Union for adults with sHTG and triglyceride levels of 880 milligrams per deciliter or higher. The Sweden-listed biopharmaceutical company holds exclusive rights to commercialize Tryngolza outside the US, excluding Canada and China, under its agreement with drug developer Ionis Pharmaceuticals.