AbbVie Meets Primary Endpoint

AbbVie, in cooperation with Neurocrine Biosciences, announced that the Phase 3 ELARIS UF-I study (M12-815) of elagolix met its primary endpoint. 

Results from the first of two pivotal Phase 3 studies demonstrated at month six that elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding with 68.5 percent (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (8.7 percent), as measured by the alkaline hematin method. The study also met all ranked secondary endpoints (p<0.001) at month six.

Uterine fibroids are the most common type of abnormal growth in a woman’s pelvis and can affect up to 80 percent of women by age 50.

“Current non-surgical treatments are limited and women suffering from uterine fibroids need more therapeutic options,” said 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.”