FDA extends review time for elagolix

12 April 2018

The US Food and Drug Administration has said that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie (NYSE: ABBV) in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain.

The Prescription Drug User Fee Act (PDUFA) date for elaglolix, which is being developed in cooperation with Neurocrine Biosciences (Nasdaq: NBIX), has been extended three months to third-quarter 2018.

In the fourth quarter of 2017, the FDA granted priority review for AbbVie's NDA for endometriosis. If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.

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