Shots:
- The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026
- Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO in adults with sHTG & TG levels ≥500 mg/dL, meeting their 1EP with ~72% fasting TG reduction at 6mos., sustained to 12mos.
- Also, 86% Tryngolza-treated pts reached TG <500mg/dL at 12mos. Tryngolza also achieved ~91% decrease in acute pancreatitis events & showed the NNT to prevent one acute pancreatitis event was 20 overall & 4 in pts with TG ≥880 mg/dL; published in The NEJM
Ref: Ionis | Image: Ionis | Press Release
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