A medicine developed by AbbVie Inc. and Neurocrine Biosciences Inc. was better at reducing heavy menstrual bleeding in women with uterine fibroids when combined with hormone therapy.
Uterine fibroids, or noncancerous tumors in the uterus, can affect 20% to 80% of women by age 50 and can cause heavy menstrual bleeding, vaginal bleeding and painful periods.
Under a late-stage study known as ELARIS UF-I, 68.5% of women with uterine fibroids experienced reduced menstrual bleeding after six months of treatment with elagolix when compared to 8.7% of those who received placebo.
ELARIS UF-I, also known as M12-815, is the first of two phase 3 studies that met its primary endpoints. Data from the study will support regulatory submissions for the drug.
Elagolix, a potential blockbuster drug, was granted the U.S. Food and Drug Administration's priority review in October 2017 as a treatment for endometriosis, a painful uterus disorder.
The regulator is expected to announce its decision on the medicine as a treatment for endometriosis in the second quarter of 2018.