AbbVie Reports Positive Topline Results From Phase 3 Elagolix Study

(RTTNews) - AbbVie (ABBV), in cooperation with Neurocrine Biosciences, Inc. (NBIX) announced that the Phase 3 ELARIS UF-I study of elagolix met its primary endpoint. The company said the results from the first of two pivotal Phase 3 studies demonstrated at month six that elagolix, in combination with low-dose hormone therapy, reduced heavy menstrual bleeding with 68.5 percent of women with uterine fibroids achieving clinical response compared to placebo.

The company said the data from the Phase 3 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.