Topline results from phase III extension study evaluating investigational elagolix in women with uterine fibroids.- AbbVie + Neurocrine Biosciences.

AbbVie, in cooperation with Neurocrine Biosciences, Inc. announced that results from the Phase III 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 III 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.

The safety profile in ELARIS UF-EXTEND was consistent with previously reported topline results from the pivotal Phase III studies and no new safety signals were identified. The most frequent adverse events reported (greater than 5 percent) were hot flush, night sweats, nausea, headache and nasopharyngitis. Reduction of bone mineral density (BMD) was also observed. Evaluation of BMD at 12 months showed women with heavy menstrual bleeding associated with uterine fibroids who received elagolix in combination with add-back therapy had less mean percent change from baseline in BMD compared to women who received elagolix alone.

Safety data will continue to be collected and analyzed. Data from the pivotal Phase III studies will be presented at a medical conference later this year and the ELARIS UF-EXTEND Phase III study data will be presented at a future medical conference. Data from the Phase III program will support regulatory submission for elagolix in uterine fibroids, anticipated in 2019.