FDA Grants Priority Review to Elagolix

The US Food and Drug Administration (FDA) grants priority review for elagolix in the management of endometriosis with associated pain, announced AbbVie.

The orally administered gonadotropin-releasing hormone or GnRH antagonist has the potential to provide significant improvements in the safety and effectiveness of the treatment of endometriosis.

"Endometriosis is often characterized by chronic pelvic pain, and can have a significant impact on patient function and quality of life," Hugh S. Taylor, MD, Chair of the Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, said in a statement. "The results presented are encouraging for patients and demonstrate that Elagolix has the potential to be an important treatment option for women suffering from pain related to endometriosis.”

If the FDA approves elagolix, it will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.

In September, AbbVie submitted a New Drug Application (NDA) to the FDA for elagolix, based on results from 2 replicated phase 3 studies — the largest to date for endometriosis. The treatment demonstrated superiority to placebo in the trials for 3 types of endometriosis-associated pain: daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.

In the trials, 1,700 women with moderate-to-severe endometriosis-related pain were randomized to examine 2 doses of elagolix —150 mg once daily and 200 mg twice daily against the placebo.

Both doses showed improvement for menstrual and non-menstrual pelvic pain at month 3 and 6, while those in the 200-mg dose group also saw a significant improvement in painful intercourse at month 3.

The safety findings were consistent across both studies with hormone suppression. The most common adverse effects included hot flush (24% for the 150 mg once daily, 42% for the 200 mg twice daily, and 7% for the placebo), headache (15%, 17%, and 10%, respectively) and nausea.

Elagolix is currently being investigated in diseases that are mediated by ovarian sex hormones like uterine fibroids and endometriosis. Phase 3 trials of elagolix for the management of uterine fibroids are ongoing. To date, elagolix has been studied in more than 40 clinical trials, totaling more than 3,000 subjects.

A press release was made available.