诺和诺德在美国推出A型血友病新药Novoeight


丹麦制药巨头诺和诺德(Novo Nordisk)近日宣布,在美国推出A型血有病新药Novoeight(turoctocog alpha),该药是一种重组凝血因子VIII产品,于2013年10月获FDA批准。

NovoEight是turoctocog alpha的商品名,该药是诺和诺德第三代重组凝血因子VIII产品,利用了最新的基因重组及蛋白纯化技术。

与市面其他重组因子VIII产品相比,Novoeight具有独特优势,可在86℉(30℃)储存长达12个月,这是目前已知的最高温度及最长储存时间。同时,Novoeight在配制后,可在86℉(30℃)存放长达4个小时,这也是目前同类产品中已知的药物配制后存放的最长时间。此外,Novoeight还具有更好的便携性,由于该药采用最新的5步纯化技术制备,因此还具有极高的纯度及质量保障。

血友病患者群体具有独特个性化的治疗需求,能够获取不同的治疗药物对该群体而言非常重要。当前,现代生活和工作的节奏非常快,而部分患者也迫切期望能有适应其忙碌生活的新产品出现,Novoeight的上市,将为A型血液病患者群体提供一种重要的治疗选择。

Novoeight的疗效和有效性在大型III期Guardian项目中得到证实,这是迄今为止在A型血友病患者中开展的最大的临床预注册试验项目,涉及超过200例A型血友病患者,包括既往接受过治疗的重度A型血友病成人及儿童患者。研究结果表明,Novoeight能够有效预防和治疗出血事件,同时患者体内未产生抑制剂。

FDA于2013年10月批准NovoEight用于A型血友病成人和儿童患者:(1)出血事件的预防和治疗;(2)围手术期管理;(3)常规预防措施,以防止或减少出血发作的频率。(来源:生物谷Bioon.com)

英文原文:Novo Nordisk introduces hemophilia therapy Novoeight in US

Danish pharmaceutical firm Novo Nordisk has introduced Novoeight (Antihemophilic Factor [Recombinant]) in the US for the treatment of people living with hemophilia A.

According to the company, Novoeight provides purity, reliability and improved portability, with the highest storage temperature for the longest period of time compared with other marketed recombinant Factor VIII products, up to 86 degrees F for 12 months.

The drug can be kept at that temperature for up to four hours after reconstitution, giving it the longest postreconstitution storage time.

In previous clinical trials, Novoeight was shown to be safe and effective with zero inhibitors confirmed in 213 previously treated patients with hemophilia A.

Novoeight offers purity through a 5-step purification process and the company intends to make the product available by mid-April 2015.

Michigan State University professor of Pediatric Hematology/Oncology and director of Pediatrics at the Centers for Bleeding and Clotting Disorders Roshni Kulkarni said: "Hemophilia patients have unique, individualized needs, so it is critical for them to have access to different therapies.

"Today's patients are looking for options that fit into their busy lives, and it's encouraging to see new treatment options that further serve patients within the bleeding disorders community."

In the US, Novoeight is approved for use in adults and children with hemophilia A for the control and prevention of bleeding, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes based on results from the guardian trials.

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