AbbVie Inc (NYSE:ABBV) has submitted a New Drug Application to the U.S. FDA for elagolix, an investigational, orally administered GnRH antagonist, being assessed for the management of endometriosis with related pain. In two replicate Phase III clinical trials, elagolix showcased superiority compared to placebo in lowering three types of endometriosis-related pain, daily menstrual pelvic pain, painful intercourse and non-menstrual pelvic pain.
Michael Severino, M.D., the EVP, R&D and Chief Scientific Officer of AbbVie, reported that the filing exhibits a vital step forward for women struggling with endometriosis and physicians who are looking for additional medical treatment alternatives to help manage this painful and chronic disease.
Elagolix possesses the potential to be a vital oral treatment alternative for women suffering from the most common indications of endometriosis and they look forward to coordinating with the FDA throughout the assessment process. The NDA is supported by report from the largest potential randomized endometriosis clinical studies conducted to date, which assessed the efficacy and safety of elagolix in almost 1,700 women with moderate-to-severe endometriosis-related pain.
The report from two replicate Phase III trials showed that, at month three as well as six, both elagolix doses led in a statistically notable higher proportion of responders for dysmenorrhea and non-menstrual pelvic pain related with endometriosis as read by the Daily Endometriosis Pain Impact scale compared to placebo. Notable improvements as against placebo were also noted at month three for the daily dose of 200 mg twice in scores for dyspareunia.
A decline in the frequency and amount of rescue pain medication use compared to placebo was also noted in the higher dose. In clinical trials, elagolix treatment lowered endometrial spread in a dose-dependent way following six months of treatment with no grave endometrial findings.
In the last trading session, the stock price of AbbVie gained 0.82% to close the day at $88.47.