FDA Delays Decision on Approval of Elagolix for Endometriosis-Associated Pain

FDA Delays Decision on Approval of Elagolix for Endometriosis-Associated Pain

The U.S. Food and Drug Administration has pushed back a decision on a new drug application (NDA) for elagolix in the treatment of endometriosis-associated pain, AbbVie and Neurocrine Biosciences recently announced.

The FDA requires the three-month extension to analyze additional information on results of liver function tests. It is now planning to make a decision by the third quarter of 2018.

Abbvie’s NDA was granted priority review in October 2017, and a decision was first expected by June 2018. Priority review is assigned to medicines with potential to significantly improve the safety and effectiveness of current treatments for serious diseases.

If approved, elagolix will be the first oral therapeutic strategy for endometriosis-associated pain in more than a decade, according to the companies.

“Based on our review of the data, we remain confident in our [NDA] for elagolix in the treatment of endometriosis-associated pain,” Michael Severino, MD, Abbvie’s executive vice president of research and development and chief scientific officer, said in a press release. “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 is supported by results from the largest randomized clinical studies of endometriosis to date. Two global Phase 3 trials (NCT01620528 and NCT01931670) tested the safety and effectiveness of elagolix in nearly 1,700 women with moderate-to-severe menstrual and nonmenstrual pain.

Results showed that elagolix at 200 mg given twice daily for up to six months reduced proliferation of endometrial tissue and pelvic pain complaints. Extended treatment for up to 12 months further resulted in nearly 50 percent of women reporting decreased average monthly menstrual and nonmenstrual pelvic pain. This benefit was observed in both trials.

Data also revealed that treatment with elagolix was well-tolerated and did not lead to any new safety concerns.

Besides endometriosis, elagolix is also being tested as a treatment for women with uterine fibroids. Recent results from two Phase 3 trials revealed that, in combination with low-dose hormone therapy, the potential medication reduces heavy menstrual bleeding in these patients.

Elagolix (ABT–620) is an oral treatment candidate that blocks GnRH receptors. This results in a decrease in the production of estrogen and progesterone in the ovaries.