Ionis Builds Case for Wider Tryngolza Use in Severe Lipid Disorders Following Positive Phase 3 Results
Ionis Pharmaceuticals reported that Tryngolza (olezarsen), its lipid-lowering drug, met primary goals in two Phase 3 trials focused on patients with severely elevated triglycerides135.
Tryngolza demonstrated a 72% mean reduction in fasting triglyceride levels compared to placebo and slashed acute pancreatitis events by 85% in these trials3.
These results support Ionis' plan to seek FDA approval by year-end 2025 to expand Tryngolza's indication to include severe hypertriglyceridemia, beyond its current approval for familial chylomicronemia syndrome (FCS)14.
Tryngolza was first approved in December 2024 for FCS, a rare inherited lipid disorder, where it recorded $25.6 million in sales for the first half of 20251.
Market analysts view these findings as positioning Tryngolza strongly in a multi-billion-dollar severe lipid disorder market, noting its proven impact in reducing both triglyceride levels and the risk of acute pancreatitis13.
In the EU, the Committee for Medicinal Products for Human Use (CHMP) has recommended Tryngolza for approval as an adjunct therapy in adults with genetically confirmed FCS, with an EC decision expected by Q4 20252.
Sources:
1. https://www.biopharmadive.com/news/ionis-tryngolza-triglycerides-core-trial-results/758987/
2. https://www.biospace.com/press-releases/tryngolza-olezarsen-recommended-for-approval-in-the-eu-by-chmp-for-familial-chylomicronemia-syndrome-fcs
3. https://www.biospace.com/drug-development/ionis-tryngolza-hits-best-case-scenario-in-late-stage-triglyceride-study
4. https://pharmatimes.com/news/ionis-shares-phase-3-results-for-olezarsen-in-moderate-hypertriglyceridaemia/