BRIEF — AbbVie's elagolix meets endpoint in uterine fibroids trial

US drugmaker AbbVie and its partner Neurocrine Biosciences have announced that the Phase III ELARIS UF-I study of elagolix met its primary endpoint.

Results from the first of two pivotal Phase III studies demonstrated at month six that elagolix, in combination with low-dose hormone therapy, reduced heavy menstrual bleeding in 68.5% of women with uterine fibroids achieving clinical response compared to 8.7% of placebo, 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% or greater reduction in menstrual blood loss volume from baseline to month six. The study also met all ranked secondary endpoints at month six.

Dawn Carlson, vice president for general medicine development, said: “Current non-surgical treatments are limited and women suffering from uterine fibroids need more therapeutic options.”