FDA delays decision on endometriosis pain drug

Apr 11, 2018

AbbieVie and Neurocrine Biosciences announced this week that the FDA is taking further time to review a marketing application for the companies’ new uterine pain medication.

The drug, elagolix, was designed to treat pain associated with endometriosis, which occurs when abnormal tissue grows outside the lining of the womb. 

The companies said that the agency plans to take an additional three months to review the application, and now plans to issue a verdict by the third quarter of this year. 

The companies have been working on developing elagolix together since 2010. Despite the delay, the companies said in a statement that their data about the drug is based on one of the largest randomized trials ever on endometriosis, and that they have full confidence in elagolix.

Read the full Reuters report.

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