FDA Approved New Treatment for Heavy Menstrual Bleeding Caused by Uterine Fibroids

The US Food and Drug Administration (FDA) has approved oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) for treating heavy menstrual bleeding associated with uterine fibroids among premenopausal women.

It is the first nonsurgical, oral medication approved by the FDA for this indication.

The approval comes after 2 phase 3 trials (ELARIS UF-I and ELARIS UF-II) showed that oriahnn significantly reduced the amount of bleeding compared with placebo. Within the first month of use, heavy menstrual bleeding caused by uterine fibroids was reduced by 50% among women taking oriahnn.

“Women who experience heavy menstrual bleeding as a symptom not only deal with the physical toll of uterine fibroids, but also the burdens surrounding its management while trying to get through with their day-to-day routines,” said Ayman Al-Hendy, MD, PhD, investigator for the ELARIS UF-2 clinical trials and professor of gynecology and director of translational research at the University of Illinois at Chicago. “This approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way.”

—Amanda Balbi

Reference

FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women. News release. Abbvie; May 29, 2020. https://news.abbvie.com/news/press-releases/fda-approves-first-oral-medication-for-management-heavy-menstrual-bleeding-due-to-uterine-fibroids-in-pre-menopausal-women.htm