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FDA accepts Shire's application for expanded use for HAE med Cinryze, action date June 20

Feb. 15, 2018 7:18 AM ETShire PLC (SHPG) StockBy: Douglas W. House, SA News Editor
  • The FDA accepts under Priority Review Shire plc's (NASDAQ:SHPG) supplemental Biologics License Application (sBLA) seeking approval to use CINRYZE (C1 esterase inhibitor [human]) to treat children as young as six years old with hereditary angioedema (HAE). The agency's action date is June 20.
  • CINRYZE is currently approved in the U.S. for adolescent and adult HAE patients.

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