FDA approves Ionis' TRYNGOLZA for severe hypertriglyceridemia, cuts pancreatitis risk 91%

IONIS PHARMACEUTICALS INC

• FDA approved TRYNGOLZA (olezarsen) as adjunct to diet to reduce triglycerides and risk of acute pancreatitis in adults with sHTG (TG ≥500 mg/dL).
• Phase 3 CORE/CORE2: fasting TG lowered up to 72% vs placebo at 6 months; acute pancreatitis events reduced up to 91%.
• 86% of patients achieved TG <500 mg/dL at 12 months; NNT to prevent one acute pancreatitis: 20 overall, 4 in highest-risk subgroup.
• Available in 50 mg or 80 mg dose, self-administered monthly via autoinjector; U.S. launch expected in July 2026.
• This is Ionis' first independent commercial launch in a prevalent disease, marking a major milestone.