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The EU approved Tryngolza for rare high-triglyceride disorder, reducing pancreatitis and improving patients' lives.
The European Union has approved Tryngolza (olezarsen), developed by Sobi and Ionis Pharmaceuticals, as an adjunct to diet for adult patients with familial chylomicronemia syndrome (FCS), a rare genetic disorder causing dangerously high triglycerides.
The approval, backed by positive results from the phase 3 Balance study, shows significant reductions in triglyceride levels and acute pancreatitis events, improving patients’ quality of life.
FCS affects up to 13 in every million people in the EU and carries a high risk of life-threatening pancreatitis.
The European Medicines Agency’s CHMP had recommended approval in July.
Sobi holds commercial rights in all countries except the U.S., Canada, and China.
La UE ha aprobado Tryngolza para el tratamiento de trastornos raros de niveles altos de triglicéridos, reduciendo la pancreatitis y mejorando la vida de los pacientes.