18-0 in favour of telaprevir

StephenW

  WASHINGTON (Dow Jones)--A Food and Drug Administration panel unanimously backed the approval of Vertex Pharmaceuticals Inc.'s (VRTX) proposed hepatitis C-drug telaprevir, saying it showed strong effectiveness, a day after also endorsing a similar product from Merck & Co. (MRK).
  The panel of non-FDA medical experts voted 18-to-0 on a question that asked whether the available data support approval of the telaprevir in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the agency approve telaprevir. The FDA usually follows the advice of its advisory panels but isn't required to.

华盛顿（道琼斯） -美国食品与药物管理面板一致支持顶点制药公司（VRTX）批准建议C型肝炎药物telaprevir，称它表现出较强的有效性，认可后，由默克公司也有类似产品的天制药（MRK）。

非美国FDA的医疗专家小组投票的问题，是否可用数据的telaprevir支持组合与其他批准丙型肝炎的药物，聚乙二醇干扰素和利巴韦林要求18至0。这次投票相当于一个建议，该机构批准telaprevir。美国食品药品管理局通常遵循其咨询小组的意见，但不要求。




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