FDA Approves New Treatment for Fibroid-Related Heavy Menstrual Bleeding

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA has approved a new combination oral product to treat heavy menstrual bleeding related to uterine fibroids in premenopausal women. Oriahnn contains elagolix (a gonadotropin-releasing hormone antagonist) plus estradiol and norethindrone acetate.

Approval was based on findings from two trials in which nearly 600 women were randomized to Oriahnn or placebo for 6 months. The primary endpoint — a reduction in heavy menstrual bleeding — was achieved by 69%–77% of women receiving the active treatment, versus 9%–11% receiving placebo. The most common side effects included hot flushes, headache, and nausea.

Oriahnn may cause bone loss and should not be used for longer than 24 months. Additionally, its label includes a boxed warning about the risks for vascular events and thrombotic or thromboembolic disorders.