AbbVie's elagolix meets in Phase III for uterine fibroids
AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-I (M12-815) trial to treat uterine fibroids. The trial is the first of two replicate Phase III trials of the non-peptide small molecule gonadotropin-releasing hormone (GnRH) antagonist in the indication. AbbVie said data from the second trial -- M12-817 -- are expected this year, with a commercial launch of elagolix to treat uterine fibroids planned for 2020.
On ELARIS UF-I's primary endpoint, oral elagolix plus estradiol/norethindrone acetate significantly reduced heavy menstrual bleeding at six months as measured by the proportion of patients achieving a clinical response per the alkaline hematin method vs. placebo (68.5% vs. 8.7%, p<0.001). A clinical response was defined as menstrual blood loss volume of less than 80 mL during month six and a ≥50% reduction in menstrual blood loss volume from baseline to six months. Ranked secondary endpoints included measures of bleeding, bleeding suppression and hemoglobin changes...