AbbVie receives FDA Priority Review for elagolix

AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.  The FDA grants priority review to medicines that it determines have potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.  AbbVie expects the Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review will be in Q2 2018.

“We are pleased that elagolix has been granted priority review by the FDA and will continue to work closely with the agency to hopefully bring this treatment to women suffering from endometriosis as soon as possible,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

The NDA is supported by data from the largest prospective randomized 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.