CHMP recommendation follows Phase 3 results showing up to 72% triglyceride reduction and an 85% reduction in acute pancreatitis events compared with placebo.
Date: October 16, 2026
Company: Ionis Pharmaceuticals, Inc.
Drug: Tryngolza (olezarsen)
Therapeutic Area: Cardiometabolic Disease
Key Highlights
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Positive CHMP Opinion: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended extending Tryngolza’s indication to adults with severe hypertriglyceridemia (sHTG) who have fasting triglyceride levels of ≥880 mg/dL (≥10 mmol/L).
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Phase 3 Efficacy: The CORE and CORE2 trials demonstrated a statistically significant placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, sustained through 12 months.
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Pancreatitis Risk: A pooled analysis of both trials showed an 85% reduction in adjudicated acute pancreatitis events over 12 months compared with placebo.
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Safety Profile: Tryngolza demonstrated a favourable safety and tolerability profile in the reported studies.
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Next Regulatory Milestone: A final decision from the European Commission is expected in the fourth quarter of 2026.
Clinical Trial Results
The positive CHMP opinion is supported by findings from the pivotal Phase 3 CORE and CORE2 studies, which evaluated the safety and efficacy of olezarsen in adults with severe hypertriglyceridemia.
| Clinical Measure | Reported Finding |
|---|---|
| Triglyceride reduction | Up to 72% at six months |
| Duration of triglyceride-lowering effect | Sustained through 12 months |
| Acute pancreatitis events | 85% reduction compared with placebo over 12 months |
| Clinical development | Phase 3 CORE and CORE2 studies |
The trial findings were published in The New England Journal of Medicine.
How Does Tryngolza Work?
Tryngolza is an RNA-targeted therapy designed to reduce the liver’s production of apolipoprotein C-III (apoC-III), a protein involved in regulating triglyceride metabolism. By targeting this protein, olezarsen helps lower triglyceride levels in the blood.
About Severe Hypertriglyceridemia
Severe hypertriglyceridemia is characterized by very high levels of triglycerides in the blood and is associated with an increased risk of acute pancreatitis, a potentially life-threatening inflammation of the pancreas.
According to the companies’ announcement, approximately two million people across the EU5 countries are living with sHTG, including around 700,000 with triglyceride levels of ≥880 mg/dL (≥10 mmol/L).
Company Statements and Commercialization
Ionis Pharmaceuticals discovered and developed Tryngolza and commercializes the medicine in the United States. Under a licensing agreement, Sobi holds exclusive commercialization rights outside the United States, excluding Canada and China.
The positive CHMP opinion represents a further regulatory milestone for both companies as they work towards potential expanded access to Tryngolza for eligible adults with severe hypertriglyceridemia in Europe.
What’s Next?
The European Commission’s anticipated decision in Q4 2026 will determine whether the recommended indication extension receives final authorization in the EU.
Source: Ionis Pharmaceuticals, Inc. — October 16, 2026.
