TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for severe hypertriglyceridemia (sHTG)
Key Highlights
- ➤CHMP recommends EU approval extension for TRYNGOLZA in adults with severe hypertriglyceridemia
- ➤European Commission decision expected in fourth quarter of 2026
- ➤TRYNGOLZA cut fasting triglycerides up to 72% versus placebo at six months
- ➤Pooled CORE and CORE2 analysis showed 85% fewer acute pancreatitis events over 12 months
- ➤Sobi holds exclusive commercialization rights outside U.S., excluding Canada and China
Expert Statements
Brett P. Monia, Chief executive officer of Ionis Pharmaceuticals
“Following TRYNGOLZA’s approval for sHTG in the U.S. in June, today’s positive CHMP opinion marks an important step towards making this treatment available to patients with sHTG in the EU”
Brett P. Monia, Chief executive officer of Ionis Pharmaceuticals
“The recommendation builds on the robust clinical evidence from the CORE and CORE2 studies and reflects the continued collaboration between Ionis and Sobi as we work towards a potential European approval.”
Lydia Abad-Franch, Head of research and development and medical affairs and chief medical officer of Sobi
“The CHMP's positive opinion reflects the strength of the clinical evidence and brings us one step closer to offering TRYNGOLZA as a new treatment option to help reduce the risk of acute pancreatitis in patients with sHTG in the EU”
Lydia Abad-Franch, Head of research and development and medical affairs and chief medical officer of Sobi
“Acute pancreatitis is a potentially life-threatening complication of sHTG that can place a significant burden on patients through frequent hospitalizations, intensive care treatment, irreversible complications and reduced quality of life.”
Lydia Abad-Franch, Head of research and development and medical affairs and chief medical officer of Sobi
“We look forward to the final decision from the EC.”
TRYNGOLZA® (olezarsen) recommended for approval in the EU by CHMP for severe hypertriglyceridemia (sHTG)
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the indication extension for TRYNGOLZA® (olezarsen) as an adjunct to diet, in combination with other lipid-lowering therapies, for the treatment of adult patients with severe hypertriglyceridemia (sHTG, fasting triglyceride levels of ≥880 mg/dL [≥10 mmol/L]). If confirmed by the European Commission (EC), TRYNGOLZA would be the first and only RNA-targeted therapy authorized in the EU for adults with sHTG and triglyceride levels ≥880 mg/dL (≥10 mmol/L). The positive CHMP opinion comes ahead of the previously anticipated timeline, with a final EC decision expected in the fourth quarter of 2026.
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