Shots:
- The P-III (CORE: n=617 & CORE2: n=446) trials assessed olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults; the US FDA’s sNDA filing is expected by 2025 end
- Both trials met their 1EP with ~72% PBO-adjusted fasting triglyceride (TG) reduction at 6mos., sustained to 12mos., while 89% (50mg) & 88% (80mg) achieved TG <880mg/dL, 86% for both reached TG <500mg/dL, plus 34% & 54% achieved TG <150 mg/dL at 12mos.
- Olezarsen achieved an 85% reduction in adjudicated acute pancreatitis events at 12mos. (7 vs 22 events) & is estimated to prevent 1 event per yr. for every 20 pts treated (NNT=20), or 1 per 4 in high-risk pts, while also improving 2EPs of apoC-III, remnant cholesterol, & non-HDL-C levels; data published in The NEJM
Ref: Ionis | Image: Ionis | Press Release
Related News:- Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome
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