Shots:
- The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned
- The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed PBO-adjusted mean reduction in TG levels of 42.5% (6mos.) & 57% (12mos.) plus reduced AP events at 12mos. with 5% (1 pt) on Tryngolza having 1 episode vs 30% (7 pts) on PBO having 11 AP episodes
- Tryngolza (RNA-targeted drug) reduces apoC-III production responsible for regulating TG & is being evaluated in 3 P-III trials (CORE, CORE2 & ESSENCE) to treat sHTG
Ref: Ionis | Image: Ionis | Press Release
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