国家药监局批准注射用维拉苷酶β上市

美港电讯
15 May

【国家药监局批准注射用维拉苷酶β上市】金十数据5月15日讯,近日,国家药品监督管理局通过优先审评审批程序批准北海康成(上海)生物科技有限公司申报的注射用维拉苷酶β(商品名:戈芮宁)上市,适用于12岁及以上青少年和成人I型和Ⅲ型戈谢病患者的长期酶替代治疗。戈谢病是一种因溶酶体中葡萄糖脑苷脂酶功能缺陷导致的常染色体隐性遗传代谢病,被纳入《第一批罕见病目录》。注射用维拉苷酶β能减少葡萄糖脑苷脂在体内的贮积,从而发挥治疗作用。该品种的上市为相关患者提供了新的治疗选择。

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