梯瓦生物仿制药TBO-filgrastim获FDA批准 发布时间：2012-8-31 来源：药品资讯网信息中心梯瓦(Teva)近日宣布,FDA批准TBO-filgrastim(TBO-粒细胞集落刺激因子,又名XM02-filgrastim)用于正在接受对骨髓有影响的化疗药物的某些癌症类型患者(non-myeloid malignancies,非骨髓恶性肿瘤),以减少严重中性粒细胞减少症(neutropenia)的持续时间。TBO-filgrastim是一种短效重组G-CSF,该药为安进(Amgen)Neupogen的生物仿制药。这是在过去十多年中在美国获批的首个新的粒细胞集落刺激因子(G-CSF)产品。目前,TBO-filgrastim在欧洲以商品名Tevagrastim销售。根据与Amgen达成的和解协议,Teva最早将于2013年11月在美国市场推出TBO-filgrastim。中性粒细胞减少症(neutropenia)是由于外周血中性粒细胞的绝对值减少而出现的一组综合征,使得患者更容易遭受潜在的危及生命的细菌感染。"我们非常高兴TBO-filgrastim获得了FDA的批准,该药将为医生及正在接受化疗的患者,提供一种新的支持性护理治疗选择,"Teva全球研发总裁及CSO Michael Hayden博士说道。"TBO-filgrastim的获批,扩展了Teva现有肿瘤学产品组合,有力地证明了Teva致力于为患者提供新治疗方案的坚定承诺。"有关TBO-filgrastim的临床研究显示,与安慰剂相比,该药能够显著减少严重中性粒细胞减少症的持续时间。在首轮21天化疗周期中,接受TBO-filgrastim治疗的患者组,严重中性粒细胞减少症持续时间为1.1天,而安慰剂组为3.8天。
JERUSALEM — Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years. Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections. Teva currently markets filgrastim in Europe under the trade name Tevagrastim®, a biosimilar to Neupogen®. Tbo-filgrastim was filed in the U.S. as a Biologics License Application (BLA) since a biosimilar approval pathway had not been established at the time of submission. Teva will market tbo-filgrastim as early as November 2013, in accordance with the settlement reached with Amgen. "As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. "The approval of tbo-filgrastim demonstrates Teva's strong commitment to providing patients with new treatment options. It expands upon Teva's existing Oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients." In studies of tbo-filgrastim, the drug was shown to have statistically significant reductions in the duration of severe neutropenia compared to placebo. During the first 21-day chemotherapy cycle, patients treated with tbo-filgrastim had severe neutropenia for an average of 1.1 days, compared with 3.8 days for those receiving placebo.
ABOUT TBO-FILGRASTIM Tbo-filgrastim is a short-acting recombinant form of G-CSF which was designed to stimulate the bone marrow to produce white bloods cells to reduce the duration of severe neutropenia in patients receiving chemotherapy associated with a clinically significant incidence of febrile neutropenia (neutropenia with fever). Tbo-filgrastim is a solution for subcutaneous injection and will be supplied as a single use, preservative-free, prefilled syringe in doses of 300mcg/0.5mL and 480 mcg/0.8mL.
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