Sobi receives positive CHMP opinion for TRYNGOLZA® (olezarsen) for the treatment of severe hypertriglyceridemia (sHTG)
· Positive CHMP opinion based on Phase 3 CORE and CORE2 results, demonstrating a statistically significant placebo-adjusted mean reduction of up to 72% in triglyceride levels and a significant 85% reduction in the rate of acute pancreatitis events with TRYNGOLZA (olezarsen) compared with placebo
· Approximately 700,000 people in the EU5 are estimated to have triglyceride levels ≥880 mg/dL (≥10 mmol/L)[i]
Sobi® today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the indication