欧盟批准Tryngolza用于罕见的高甘油三症,减少胰腺炎并改善患者的生活.
The EU approved Tryngolza for rare high-triglyceride disorder, reducing pancreatitis and improving patients' lives.
欧洲联盟已批准由Sobi和Ionis制药公司开发的Tryngolza(olezarsen),作为患有家庭性子宫微血糖综合症(CFS)的成年病人饮食的辅助剂,这是一种罕见的遗传障碍,导致危险的高浓度三甘酸盐。
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.
该批准得到了 3 期平衡研究的积极结果的支持,显示甘油三酯水平和急性胰腺炎事件显着降低,改善了患者的生活质量。
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.
欧盟每百万人中就有多达13人罹患全氟辛烷磺酰胺,并极有可能患危及生命的胰腺炎。
FCS affects up to 13 in every million people in the EU and carries a high risk of life-threatening pancreatitis.
欧洲药品署的CHMP曾于7月建议批准。
The European Medicines Agency’s CHMP had recommended approval in July.
索比公司拥有除美国、加拿大和中国以外的所有国家的商业权利。
Sobi holds commercial rights in all countries except the U.S., Canada, and China.