AbbVie’s Elagolix Wins FDA Priority Review to Manage Endometriosis with Associated Pain

AbbVie’s Elagolix Wins FDA Priority Review to Manage Endometriosis with Associated Pain

The U.S. Food and Drug Administration (FDA) has granted priority review to AbbVie’s investigational medicine, Elagolix — formerly known as ABT-620 — for managing endometriosis with associated pain.

Elagolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, which means the drug binds to GnRH receptors in the pituitary gland, blocking its ability to produce hormones – including estrogen – that promote endometriosis.

In September, AbbVie and partner Neurocrine Biosciences submitted to the FDA a new drug application for Elagolix after positive results of two Phase 3 clinical trials (NCT01620528 and NCT01931670).

Data from the trials, which involved some 1,700 women with endometriosis and moderate-to-severe menstrual and non-menstrual pain, supports Elagolix’s therapeutic potential in reducing endometriosis-associated pain when compared to placebo. Researchers tested two doses of Elagolix – 150 mg once daily or 200 mg twice daily – versus placebo and measured the effects at three and six months of treatment.

Both doses significantly reduced the proportion of women complaining of menstrual and non-menstrual pain versus placebo-treated patients, at both month three and six. Moreover, after six months of therapy with the highest dose (200 mg), Elagolix reduced proliferation of endometrial tissue.

Patients treated with the 200 mg dose reported additional benefits, including a reduction in pain during intercourse after three months of treatment. They also relied less on pain relievers, including nonsteroidal anti-inflammatories and opioids.

FDA’s priority review is assigned to medicines the agency recognizes have the potential to significantly improve the safety and effectiveness of current therapies for serious diseases. Moreover, the priority designation means that the review period for AbbVie’s new drug application will be six months instead of ten, meaning a final decision will come by June 2018.

If accepted, Elagolix would become the first new oral therapeutic option for endometriosis-associated pain in more than a decade.

“We are pleased that Elagolix has been granted priority review by the FDA and will continue to work closely with the agency to hopefully bring this treatment to women suffering from endometriosis as soon as possible,” Dr. Michael Severino, AbbVie’s chief scientific officer as well as executive vice president for research and development, said in a press release.