FDA Approves New Option for Heavy Menstrual Bleeding

The FDA has approved Oriahnn (estrogen and progestin combination consisting of elagolix, estradiol and norethindrone acetate) for the treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

The efficacy of the treatment was examined in 2 clinical trials with a total of 591 premenopausal women with heavy menstrual bleeding, defined as at least 2 menstrual cycles with greater than 80 mL of menstrual blood loss. The women were assigned to either Oriahnn or placebo for 6 months. In the first study, 68.7% of those who received the new treatment option achieved the endpoint of 50% or greater reduction in blood loss compared with baseline during the final month, compared with 8.7% of those in the placebo group. In the second study, 76.5% of patients receiving Oriahnn achieved the endpoint, compared with 10.5% of the placebo group patients.

Oriahnn may cause bone loss over time and should not be taken for more than 24 months. The most common adverse effects were hot flushes, headache, fatigue, and irregular vaginal bleeding. It includes a boxed warning on the risk of vascular events and thrombotic or thromboembolic disorders.

—Michael Potts

Reference:

FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women. News release. US Food and Drug Administration. May 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women.