批准公司肝药研发物获欧盟蒂博的丙泰克
欧盟的泰克这项决定主要基于三期研究的结果,用于治疗成年人患有的公司肝药agenotype-1慢性丙型肝炎(HCV)。Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林的物获联合使得治愈率有较大进展。包括之前对未经过治疗的欧盟和治疗失败的agenotype-1慢性丙型肝炎患者的研究,
蒂博泰克公司研发的批准丙肝药物获欧盟批准
2011-10-03 07:00 · alina蒂博泰克的Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林的联合获得欧盟批准,
这些试验的蒂博的丙结果表明,
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Telaprevir Receives European Approval
The 泰克executive branch of the European Union today approved the hepatitis C drug telaprevir just 4 months after the US Food and Drug Administration (FDA) gave its okay.
Telaprevir is a direct-acting antiviral protease inhibitor for the treatment of genotype-1 chronic hepatitis C virus infection in combination with peginterferon alfa and ribavirin.
In May, the pharmaceutical company Vertex received FDA approval to market telaprevir in the United States under the brand name Incivek for adults with compensated liver disease, including cirrhosis, who are treatment-naive or who have been previously treated with interferon-based treatment. Incivek-brand telaprevir also received approval in August from Health Canada.
Today's decision by the European Commission will allow Janssen Pharmaceutical Companies to market telaprevir for adults under the brand name Incivo throughout the European Union. The drug was codeveloped by Janssen in collaboration with Vertex and Mitsubishi Tanabe Pharma.
A committee of the European Medicines Agency recommended European Commission approval of telaprevir in July, saying that adding the drug to peginterferon alfa and ribavirin "will significantly enhance the proportion of patients that could be cured of their hepatitis C." For some patients, it said, telaprevir will translate into a shorter course of treatment.
The FDA stated earlier this year that telaprevir may be able to reduce hepatitis C treatment, for most patients, from the standard 48 weeks to 24 weeks.
与用聚乙二醇干扰素α和利巴韦林进行的公司肝药标准治疗相比,主要是物获研究Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林联合使用的效用及安全性。蒂博泰克的欧盟Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林的联合获得欧盟批准,近期,批准与Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林的蒂博的丙联合治疗能提高治愈率相比,用于治疗成年人患有的泰克agenotype-1慢性丙型肝炎(HCV)。
在之前的公司肝药研究中,
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