Sobi’s olezarsen recommended for EU approval in severe hypertriglyceridaemia
pharmafile | October 27, 2026 | News story | | Chronic Diseases, EMA, Pain, Pharmacy, drug development, regulatory
Sobi’s olezarsen (TRYNGOLZA) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its use in adults with severe hypertriglyceridaemia (sHTG) and fasting triglyceride levels of at least 880 mg/dL (10 mmol/L).
The recommendation, which covers use alongside diet and other lipid-lowering therapies, is based on results from the phase 3 CORE and CORE2 trials. A final decision from the European Commission is expected in the fourth quarter of 2026.
Across the studies, olezarsen demonstrated a placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, sustained through 12 months. A pooled analysis also found an 85% reduction in the rate of acute pancreatitis events over 12 months compared with placebo.
The trials enrolled 1,063 adults with triglyceride levels of at least 500 mg/dL who were receiving standard-of-care treatment. Participants received subcutaneous olezarsen at 50 mg or 80 mg, or placebo, every four weeks for 12 months.
Severe hypertriglyceridaemia is associated with an increased risk of acute pancreatitis, a potentially life-threatening condition that can cause severe abdominal pain, require prolonged hospitalisation and result in lasting organ damage.
Sobi estimates that around 700,000 people across the EU5 have triglyceride levels of at least 880 mg/dL. If approved, olezarsen would be the first RNA-targeted therapy authorised in the EU for this patient group, according to the company.
“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,” said Lydia Abad-Franch, Chief Medical Officer and Head of R&D and Medical Affairs at Sobi.
Olezarsen was discovered and developed by Ionis Pharmaceuticals, which markets the medicine in the US. Sobi holds exclusive commercialisation rights outside the US, excluding Canada and China.
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