承認過程を調査へ　エーザイのアルツハイマー薬―米厚生省

　【ニューヨーク時事】米厚生省の監査部門は４日、日本の製薬大手エーザイと米バイオ医薬品大手バイオジェンが共同開発したアルツハイマー病治療薬「アデュカヌマブ」をめぐり、米食品医薬品局（ＦＤＡ）による承認過程を調査すると表明した。
　ＦＤＡは同薬を優先審査の対象に指定した上で６月に承認し、同月に使用が始まった。ただ、専門家で構成するＦＤＡの諮問委員会が承認に反対の立場を取っていたことから、ＦＤＡの決定が波紋を呼んでいた。ウッドコックＦＤＡ長官代行は７月、厚生省の監査部門に対し、承認に至るまでのＦＤＡとバイオジェンとのやりとりが適切だったか、調査するよう求めていた。（2021/08/05-10:04）

The Office of Inspector General at the U.S. Department of Health and Human Services said Wednesday that it will review the process of the U.S. Food and Drug Administration's approval of a new remedy for Alzheimer's disease.
   The remedy, called aducanumab, was developed jointly by Japan's Eisai Co. and U.S. biopharmaceutical company Biogen Inc.
   The FDA gave its approval for the drug in June with the use of its accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions. The remedy became available for use in the same month.
   However, concerns have been raised over the FDA's decision as an advisory committee to the FDA voted against the approval.
   Acting FDA Commissioner Janet Woodcock in July called on the OIG to investigate whether interactions between the FDA and Biogen during the approval process were appropriate.