TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for severe hypertriglyceridemia (sHTG)
Ionis announced that the EMA's CHMP has adopted a positive opinion recommending TRYNGOLZA (olezarsen) as an adjunct to diet, with other lipid-lowering therapies, for adults with severe hypertriglyceridemia in the EU. The recommendation came ahead of the previously anticipated timeline; if confirmed by the European Commission, TRYNGOLZA would be the first and only RNA-targeted therapy authorized in the EU for sHTG with triglycerides >=880 mg/dL, with a final EC decision expected in Q4 2026.
Key figures
- Drug Name
- TRYNGOLZA (olezarsen)
- Phase Of Trial
- Phase 3
- Core n
- 617
- Core2 n
- 446
- Tg reduction pct
- up to 72% at six months (placebo-adjusted mean reduction in fasting triglycerides)
- Eu5 shtg patients
- approximately 2 million, including approximately 700,000 with TG >=880 mg/dL
- Ec decision timing
- Q4 2026
- Pancreatitis reduction pct
- 85% reduction in adjudicated acute pancreatitis events over 12 months vs placebo (pooled CORE/CORE2)
AI analysis
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