AbbVie Inc and Neurocrine Biosciences Inc said the U.S. Food and Drug Administration (FDA) 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 request comes a month after it extended the time to review rival Allergan Plc’s uterine fibroids drug Esmya.
Four reports of serious liver injury in patients treated with the drug caused European regulators to open a review into Allergan’s rival drug in December.
“This is just the FDA being consistent in their request for similar indications,” said Baird analyst Brian Skorney, adding that he did not think the issue was specific to Elagolix.
FDA is now expected to make its decision on AbbVie’s drug in the third quarter of 2018, three months later than initially expected.
Neurocrine and AbbVie are also testing Elagolix for the treatment of uterine fibroids in late-stage clinical studies.
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.
(Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing by Bernard Orr)