Shots:
- Ionis has reported P-III (CORE: n=617 & CORE2: n=446) trials data assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in adults with severe hypertriglyceridemia (sHTG); the US FDA’s sNDA submission expected by year end
- Both studies met their 1EP, with CORE showing reduction in fasting triglycerides by 72% (80mg) & 63% (50mg) vs 0.5%, while CORE2 depicted 55% & 49% reductions vs 14%
- Both studies also met their 2EP, with olezarsen showing an 85% reduction in acute pancreatitis events in a pooled analysis of treatment groups across 12mos.; data to be presented at future meeting
Ref: Ionis| Image: Ionis | Press Release
Related News:- Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)
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