Posted by Michael Wonder on 10 Apr 2018
AbbVie and Neurocrine Biosciences announce PDUFA target date of Q3 2018 for elagolix in endometriosis-associated pain
10 April 2018 - FDA requires extended time for review of additional information in new drug application.
AbbVie announced notification by the U.S. FDA that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its new drug application for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act date has been extended three months to Q3 2018.
In Q4 2017, the FDA granted priority review for AbbVie's application for endometriosis. The FDA grants priority review to medicines it determines have potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.
