Posted by Michael Wonder on 28 Oct 2017
AbbVie receives U.S. FDA priority review for investigational oral treatment elagolix for the management of endometriosis with associated pain
27 October 2017 - If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.
AbbVie today announced that the U.S. FDA has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, being investigated for the management of endometriosis with associated pain. AbbVie expects the Prescription Drug User Fee Act date for the FDA to complete its review will be in Q2 2018.
The NDA is supported by data from the largest prospective randomised clinical trials conducted to date for endometriosis. The safety and efficacy of elagolix were evaluated in nearly 1,700 women with moderate-to-severe endometriosis-associated pain.
