AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018.
In Q4 2017, the FDA granted priority review for AbbVie’s NDA for endometriosis. The FDA grants priority review to medicines it determines have potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.
“Based on our review of the data, we remain confident in our New Drug Application for elagolix in the treatment of endometriosis-associated pain,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Elagolix has the potential to be an important new treatment option for women suffering from endometriosis and we are committed to working with the FDA to bring this therapy to patients.”
The NDA for elagolix 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. Clinical trial data demonstrated elagolix was well-tolerated and significantly reduced the three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.
Filed Under: Drug Discovery
