蒂博泰克公司研发的蒂博的丙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，用于治疗成年人患有的泰克agenotype-1慢性丙型肝炎（HCV）。

近期，公司肝药蒂博泰克的物获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，用于治疗成年人患有的欧盟agenotype-1慢性丙型肝炎（HCV）。

在之前的批准研究中，包括之前对未经过治疗的蒂博的丙和治疗失败的agenotype-1慢性丙型肝炎患者的研究，与用聚乙二醇干扰素α和利巴韦林进行的泰克标准治疗相比，Incivo （telaprevir）与聚乙二醇干扰素α和利巴韦林的公司肝药联合使得治愈率有较大进展。

欧盟的物获这项决定主要基于三期研究的结果，主要是欧盟研究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。

这些试验的批准结果表明，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，用聚乙二醇干扰素α和利巴韦林进行的泰克标准疗法治疗未经治疗的患者却能使病情复发。

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Telaprevir Receives European Approval

The 公司肝药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.

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