Shots:
- The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026
- sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults
- Both trials showed PBO-adjusted reduction in triglyceride (TG) levels of ~72% & an 85% reduction in acute pancreatitis events, plus ~90% olezarsen-treated pts reached TG levels <500mg/dL; results were published in The NEJM
Ref: Ionis | Image: Ionis | Press Release
Related News: The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)
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