Health
EMA validates indication extension application for Tryngolza® (olezarsen) for the treatment of severe hypertriglyceridemia (sHTG)
Sobi® (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated an indication extension application for Tryngolza® (olezarsen) for the treatment of adult patients with severe hypertriglyceridemia (sHTG) ≥880 mg/dL (≥10 mmol/L). Patients with elevated triglyceride levels have substantially higher risks of all-cause mortality, atherosclerotic cardiovascular events, and acute pancreatitis[1].
About this update from Swedish Orphan Biovitrum Ab
[{"type":"text","content":"STOCKHOLM, March 30, 2026 /PRNewswire/ -- Sobi® (STO: SOBI) today announced that the European Medicines Agency (EMA) has validated an indication extension application for Tryngolza® (olezarsen) for the treatment of adult patients with severe hypertriglyceridemia (sHTG) ≥880 mg/dL (≥10 mmol/L). Patients with elevated triglyceride levels have substantially higher risks of all-cause mortality, atherosclerotic cardiovascular events, and acute pancreatitis[1].","length":459,"tagName":"p"},{"type":"text","content":"The submission is supported by results from the pivotal Phase 3 CORE and CORE2 studies, which were published in the New England Journal of Medicine in 2025[2].","length":159,"tagName":"p"},{"type":"text","content":""Tryngolza is the only pharmacological therapy to demonstrate a reduction in the risk of acute pancreatitis in patients with severe hypertriglyceridemia. If approved, it could offer an important therapeutic option to help prevent this life-threatening condition, which can place a significant burden on patients due to frequent hospitalisations, intensive treatment, persistent symptoms and reduced quality of life," said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi. "Sobi's marketing authorisation application reflects the growing body of clinical evidence supporting Tryngolza and our commitment to improving treatment options for people living with sHTG."","length":731,"tagName":"p"},{"type":"text","content":"Olezarsen is developed by Ionis Pharmaceuticals. Sobi and Ionis entered into a licence agreement under which Sobi has exclusive rights to commercialise Tryngolza in ex-U.S. geographies except Canada and China. Tryngolza® (olezarsen) was approved in the European Union in September 2025 as an adjunct to diet for the treatment of adult patients with genetically confirmed familial chylomicronemia syndrome (FCS).","length":416,"tagName":"p"},{"type":"text","content":"About Severe Hypertriglyceridemia (sHTG) ","length":40,"tagName":"p"},{"type":"text","content":"Severe hypertriglyceridemia (sHTG) is defined by severely high triglycerides ≥500 mg/dL (≥5,65 mmol/L) and triglyceride levels ≥880 mg/dL (≥10 mmol/L) are often associated with the increased accumulation of chylomicrons in the blood and with an increased risk of acute pancreatitis and...