Shots:
- Sobi has reported pooled subgroup analysis (n=455) from P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (olezarsen; 50 or 80mg, SC, Q4W) vs PBO in adults with severe hypertriglyceridemia (sHTG) & triglyceride (TG) levels ≥500 mg/dL
- Trial showed PBO-adjusted TG reductions of 66% (80mg) & 59% (50mg) at 6mos. in pts with TGs ≥880mg/dL, while also reducing remnant cholesterol by 64% & 53% and non-HDL-C by 35% & 27%, respectively; Overall, 85% treated-pts reached TGs <10mmol/L
- In Mar 2026, the EMA validated an indication extension application for Olezarsen in adults with sHTG & TGs ≥880mg/dL, while in Feb 2026, the US FDA granted priority review to its sNDA for sHTG (TGs ≥500mg/dL) with a PDUFA date of Jun 30, 2026
Ref: PRnewswire | Image: Sobi | Press Release
Related News: Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN
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