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Tryngolza ® (olezarsen) approved in the European Union for familial chylomicronemia syndrome (FCS)
Sobi® (STO: SOBI), a global biopharmaceutical company dedicated to delivering innovative treatments for patients with rare diseases, and Ionis Pharmaceuticals, Inc. today announced that Tryngolza® (olezarsen) has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The approval follows the positive opinion of the Committee for Medicinal Products for Human Use.
About this update from Swedish Orphan Biovitrum Ab
[{"type":"text","content":"STOCKHOLM, Sept. 19, 2025 /PRNewswire/ -- Sobi® (STO: SOBI), a global biopharmaceutical company dedicated to delivering innovative treatments for patients with rare diseases, and Ionis Pharmaceuticals, Inc. today announced that Tryngolza® (olezarsen) has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The approval follows the positive opinion of the Committee for Medicinal Products for Human Use.","length":516,"tagName":"p"},{"type":"text","content":"The approval is based on positive data from the Phase 3 Balance study, in which Tryngolza 80 mg demonstrated a statistically significant reduction in fasting triglyceride levels at six months that was sustained through 12 months. Additionally, Tryngolza demonstrated a substantial and clinically meaningful reduction in acute pancreatitis events over 12 months. Tryngolza showed a favourable safety and tolerability profile. Study results were published in The New England Journal of Medicine (NEJM).","length":505,"tagName":"p"},{"type":"text","content":"Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA) and Chief Medical Officer at Sobi, said, "Tryngolza is the next step in our support for the FCS community in Europe. It has a strong safety and efficacy profile, with significant reductions in triglyceride levels and a notable decrease in acute pancreatitis events, which impact morbidity, mortality, and quality of life. This builds on our commitment to FCS that began with Waylivra (volanesorsen), the only approved treatment for FCS in Europe until now. With the European Commission's approval of Tryngolza for FCS, we are looking forward to providing this therapy to eligible patients with this rare and debilitating condition across the EU."","length":766,"tagName":"p"},{"type":"text","content":"FCS is a rare and genetic form of severe hypertriglyceridemia (sHTG). People with FCS often have extremely high levels triglyceride levels, and are at high risk of developing acute pancreatitis, which can be life-threatening. In the EU, FCS is estimated to impact up to 13 people per million.","length":292,"tagName":"p"},{"type":"text","content":""The EU approval of Tryngolza is a significant advance for the...