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标题: 18-0 in favor of boceprevir [打印本页]

作者: StephenW    时间: 2011-4-28 05:24     标题: 18-0 in favor of boceprevir

  WASHINGTON (Dow Jones)--A Food and Drug Administration panel backed the use of Merck & Co.'s (MRK) hepatitis C drug boceprevir, calling the product a game-changing advance in the treatment of the disease.
  The panel of non-FDA medical experts voted 18-0 in favor of a question that asked whether the available data support approval of the product in combination with other hepatitis C drugs, pegylated interferon and ribavirin. The vote amounts to a recommendation that the agency approve boceprevir, which Merck has proposed selling under the brand name Victrelis.

华盛顿(道琼斯) -美国食品与药物管理面板支持的默克公司的(MRK)的C型肝炎药物boceprevir使用,称该产品在治疗疾病改变游戏规则的进步。

非美国FDA的医疗专家小组投票的问题,无论是现有的数据相结合的产品支持与其他批准丙型肝炎的药物,聚乙二醇干扰素和利巴韦林问青睐18-0。这次投票相当于一个建议,该机构批准boceprevir,其中默克公司提出的商标名Victrelis销售。





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