FDA Focuses on REMS Of Amgen sBLAs

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FDA Focuses on REMS Of Amgen sBLAs

机译：FDA专注于Amgen sBLA的REMS

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The FDA has been focusing its attention on proposed risk evaluation and mitigation strategies (REMS) for Amgen's pending applications for Nplate and Enbrel. "The establishment of... REMS programs is becoming increasingly important in our interactions with the FDA," Roger Perlmutter, Amgen executive vice president of R&D, said earlier this week during the firm's second-quarter earnings call. The agency has a special focus on its assessment of the REMS for chronic thrombocytopenia purpura treatment Nplate (romiplostim), he said. The FDA recently missed its deadline to issue a decision on Nplate, but the company is optimistic that one will be made shortly (WDL, July 28).

机译：FDA一直将注意力集中在针对Amgen即将批准的Nplate和Enbrel申请的拟议风险评估和缓解策略（REMS）上。 “建立... REMS计划在我们与FDA的互动中变得越来越重要，” Amgen研发执行副总裁Roger Perlmutter在本周初的第二季度财报电话会议上表示。他说，该机构特别重视对REMS用于慢性血小板减少性紫癜治疗Nplate（romiplostim）的评估。 FDA最近错过了发布关于Nplate的决定的截止日期，但该公司对不久后做出决定表示乐观（WDL，7月28日）。

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《Washington Drug Letter》 |2008年第30期|p.58|共2页
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2. FDA finalizes REMS program for ESAs; Amgen continues to study risks. [J] . Brower V Journal of the National Cancer Institute . 2010,第9期

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FDA Focuses on REMS Of Amgen sBLAs

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