FDA needs more time to review AbbVie, Neurocrine's uterine pain drug

FILE PHOTO: A screen displays the share price for pharmaceutical maker AbbVie on the floor of the New York Stock Exchange July 18, 2014. REUTERS/Brendan McDermid

(Reuters) - AbbVie Inc and Neurocrine Biosciences Inc said on Tuesday the U.S. Food and Drug Administration notified the companies that it requires more time to review the marketing application for their uterine pain drug.

The agency requested more time to review additional information regarding the results of liver function tests provided by AbbVie in connection with the application for Elagolix in endometriosis-associated pain, the companies said.

The FDA is now expected to make its decision in the third quarter of 2018, three months later than initially expected.

Endometriosis occurs when the lining of the uterus grows outside of the womb, leading to chronic pelvic pain. It is the leading cause of infertility.

AbbVie said the marketing application for Elagolix was based on data from the largest prospective randomized clinical trials conducted to date for endometriosis, and that it remained confident in its application for the drug.

In June 2010, Neurocrine and AbbVie entered into an exclusive worldwide collaboration to develop and commercialize Elagolix.

Neurocrine’s shares were down 5.3 percent in premarket trading.

Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing by Bernard Orr