AbbVie, a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc., announced that results from the Phase 3 ELARIS UF-EXTEND extension study (MI2-816) showed at month 12 that elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol 1.0 mg / norethindrone acetate 0.5 mg), reduced heavy menstrual bleeding with 87.9 percent of women with uterine fibroids achieving clinical response.
This result is consistent with that observed in the two pivotal Phase 3 studies, ELARIS UF-I and ELARIS UF-II, in which 68.5 percent and 76.2 percent of women with uterine fibroids who received elagolix with add-back therapy for six months achieved clinical response, respectively. Clinical response was defined as menstrual blood loss volume of less than 80 mL and a 50 percent or greater reduction in menstrual blood loss volume from baseline to their final month. Secondary endpoint results in the extension study were also consistent with that observed in the pivotal studies.
Uterine fibroids are the most common type of benign abnormal growth in a woman’s pelvis. Most women will develop fibroids at some point in their lives. Fibroids can be asymptomatic, but in approximately 25 percent of women, they can cause symptoms, such as heavy menstrual bleeding, painful periods, vaginal bleeding at times other than menstruation, and anaemia. African American women are more likely to experience fibroids and do so at a younger age.
Data from the pivotal Phase 3 studies will be presented at a medical conference later this year and the ELARIS UF-EXTEND Phase 3 study data will be presented at a future medical conference. Data from the Phase 3 program will support regulatory submission for elagolix in uterine fibroids, anticipated in 2019.
Dawn Carlson, M.D., M.P.H., vice president, general medicine development said, “Women with uterine fibroids are in need of additional medical management options that could help address unresolved symptoms. The results from this extension study provide additional information on the use of elagolix for up to 12 months in the management of heavy menstrual bleeding associated with uterine fibroids.”