| 第一个凝血因子-Idelvion(coagulation factor IX(recombinant), albumin fusion protein)获美国FDA批准 2016年3月4日,美国食品和药品监督管理局(FDA)批准Idelvion，凝血因子IX (重组)，白蛋白融合蛋白，为在有血友病B儿童和成年中使用。Idelvion是在美国第一个被批准的凝血因子-白蛋白融合蛋白产品，和被修饰在血中持续更长时间的第二个因子IX融合蛋白产品。 美国FDA的生物制品评价和研究中心主任Peter Marks，M.D.，Ph.D.说：“Idelvion的批准为儿童和成年有血友病B有助于预防或控制出血和减低出血发作的频数提供另一个重要的治疗选择。” 根据美国疾病控制和预防中心，血友病B是一种罕见遗传性出血疾病阻止血液正常地凝固。该疾病主要地影响男性和，罕见地，女性。有血友病B人们可能经受潜在地严重出现的反复发作，主要地至关节，它可能被出血损伤。 Idelvion被用于替代因子IX，一种天然地存在凝血因子，有血友病B人们中缺失(功能地缺陷)或缺陷(也被称为先天性因子IX缺乏或Christmas疾病)。Idelvion是通过produced by 重组 DNA技术连接因子IX至白蛋白生产，白蛋白是一种血液中发现蛋白，它负责当产品静脉给予后持续更长时间。Idelvion是适用为需要时使用控制和预防出血发作，手术后出血的处理(围手术期)和作为常规预防措施减少出血发作的频数。为了预防Idelvion潜在地需要比未经修饰的因子IX注射频数较少。 在两项多中心研究评价Idelvion的安全性和疗效，其中包括总共90例有血友病B成年和儿童患者有年龄1和61岁间。Idelvion 被证实在时有效控制出血发作和处理围手术出血。 Idelvion用作为预防导致一个现状减少每年自发性出血发作率尽管较低频数Idelvion的输注。研究没有确定安全性担忧。对Idelvion观察到最常见副作用是头痛。 Idelvion由总部在宾夕法尼亚普鲁士国王CSL Behring公司制造。 Idelvion(coagulation factor IX (recombinant), albumin fusion protein) FDA approved: Yes (First approved March 4th, 2016) Brand name: Idelvion Generic name: coagulation factor IX (recombinant), albumin fusion protein Company: CSL Behring Treatment for: Hemophilia B Idelvion (coagulation factor IX (recombinant), albumin fusion protein) is a recombinant human blood coagulation factor indicated for the control and prevention of bleeding episodes in patients with hemophilia B. About Hemophilia B Hemophilia B is a congenital bleeding disorder characterized by deficient or defective factor IX. Hemophilia B affects more than 10,000 people throughout Europe according to the European Haemophila Consortium. About PROLONG-9FP The CHMP positive opinion is based on the PROLONG-9FP clinical development program. PROLONG-9FP includes Phase I through Phase III open-label, multicenter studies evaluating the safety and efficacy of IDELVION® in adults and children (ages 1 to 61 years) with hemophilia B (FIX ≤ 2%). The data from PROLONG-9FP showed median annualized spontaneous bleeding rates (AsBR) of zero and factor IX activity levels above 5 percent in patients using IDELVION® prophylactically. According to the World Federation of Hemophilia, patients with factor IX activity levels above 5 percent are considered to have mild hemophilia. This result was achieved for both 14-day dosing and 7-day dosing. The data for on-demand therapy showed that 93.6 percent of bleeds were controlled with one infusion, while 98.6 percent were controlled with one or two infusions. The most common adverse reactions in clinical trials were injection site reactions and headache. Data from PROLONG-9FP were recently published in the American Society of Hematology’s publication Blood. About IDELVION CSL Behring engineered IDELVION® to extend the half-life of recombinant factor IX through fusion with recombinant albumin. CSL Behring selected recombinant albumin as its fusion partner for its coagulation factor proteins due to its long physiological half-life. IDELVION® is approved in Canada and regulatory agencies in the U.S., Australia, Switzerland and Japan are also currently reviewing CSL Behring’s license applications for IDELVION®. For more information about CSL Behring's recombinant coagulation factor products in development to treat hemophilia, visit http://www.cslbehring.com/products/bleeding-disorders/novel-recombinant-hemophilia-treatments. Bhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm489266.htm |
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美国FDA批准第一个凝血因子-白蛋白融合蛋白治疗血友病简介：
第一个凝血因子-Idelvion(coagulation factor IX(recombinant), albumin fusion protein)获美国FDA批准2016年3月4日,美国食品和药品监督管理局(FDA)批准Idelvion，凝血因子IX (重组)，白蛋白融合蛋白，为 ... 责任编辑：admin
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