AbbVie and Neurocrine 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 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.
In November of 2017 Abbvie announced results from a Ph III trial investigating the use of elagolix for Management of Endometriosis with Associated Pain. The extension study investigated long term use of elagolix at 150mg and 200mg doses.
One concern with long term use of GnRH antagonists is potential bone mineral density (BMD) loss. In the study, women did experience decreases in BMD from baseline at month 12. However all of women in the 150 mg group had a BMD z-score within the age-adjusted normal threshold. One woman in the 200 mg group had a BMD z-score below -2.0,which is the age-adjusted normal threshold.
Elagolix is currently being investigated in diseases that are mediated by ovarian sex hormones, such as uterine fibroids and endometriosis. To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects.