Data from Pharmawand - Curated by EPG Health - Date added 14 March 2018
AbbVie announced that the Phase III ELARIS UF-II study (M12-817) of elagolix met its primary endpoint in women with uterine fibroids. Results from the second of two pivotal Phase III studies demonstrated at month six 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 76.2 percent (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (10.1 percent), as measured by the alkaline hematin method.
Clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a 50 percent or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints (p<0.02) at month six. The overall safety profile for elagolix was consistent with what was observed in Phase II studies and the first Phase III study (ELARIS UF-I) in uterine fibroids. Data from the ELARIS UF-II Phase III study will support regulatory submissions for elagolix.
Safety data, including most common adverse events, continue to be collected in this ongoing study. The topline results from this six-month primary analysis were consistent with topline results from the ELARIS UF-I study reported in February 2018 and will be presented at an upcoming medical conference. Women in the study will continue in either post-treatment follow-up or a blinded six-month extension study.0>0>