治疗血友病A新药:聚乙二醇重组抗血友病因子

Pegylated antihemophilic factor(recombinant):a new drug in treatment of patient with hemophilia A

聚乙二醇重组抗血友病因子(Adynovate)建立在重组抗血友病因子(Advate)基础上,是聚乙二醇化的重组凝血因子Ⅷ,用于成人和青少年血友病A患者出血发作的按需治疗与控制以及常规预防治疗以减少出血发作的频次。2015年11月13日,美国FDA批准Adynovate上市。Adynovate的临床疗效和安全性与Advate相似,但Adynovate在生物体内具有更长的半衰期,作用时间更长,可以减少给药频次。

Adynovate （pegylated antihemophilic factor （recombinant）） is a pegylated full-length rFⅧ based on the marketed antihemophilic factor （recombinant） product Advate. Adynovate is indicated for on- demand treatment and control of bleeding episodes in adult and adolescent patients with hemophilia A, as well as routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Adynovate has been approved by U. S. FDA on November 13, 2015. Adynovate has similar clinical efficacy and safety with Advate. Due to increased half-life compared to Advate, Adynovate has longer acting in the body and the frequency can be reduced.