A phase III study of elagolix for women with uterine fibroids by AbbVie and Neurocrine Biosciences has met its primary endpoint.
Results from the first two pivotal phase III studies demonstrated at six months that elagolix in combination with a low-dose hormone therapy reduced heavy menstrual bleeding in 68.5 per cent of women with a uterine fibroids clinical response compared to the placebo at 8.7 per cent. This was 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 per cent or greater reduction in menstrual blood loss volume from baseline to month six.
Uterine fibroids are the most common type of abnormal growth in a woman’s pelvis and can affect up to 80 per cent of women by age 50. Fibroids can be asymptomatic, but in approximately 25 per cent of women, fibroids can cause symptoms, such as heavy menstrual bleeding, painful periods, vaginal bleeding at times other than menstruation, and anemia. African American women are more likely to experience fibroids and do so at a younger age.
“Current non-surgical treatments are limited and women suffering from uterine fibroids need more therapeutic options,” says Dawn Carlson, M.D., M.P.H., vice president, general medicine development. “The results from this study represent a significant advancement in the development of elagolix and demonstrate our continued commitment to address serious disease.”
Hypoestrogenic effects, such as hot flush and reduction in bone mineral density, from elagolix treatment were observed in the study. In addition, the overall safety profile for elagolix was consistent with what was observed in Phase II studies in uterine fibroids. Data from the Phase III study will support regulatory submissions for elagolix and will be presented at an upcoming medical conference. Safety data, including most common adverse events, are currently being analyzed.
The topline results are from a six-month primary analysis. Women in the study will continue in either post-treatment follow-up or a blinded six-month extension study.