The medication, marketed as Oriahnn, is an estrogen and progestin combination product that consists of elagolix, estradiol, and norethindrone acetate capsules packaged together for oral use, according to an .
“Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding,” Christine P. Nguyen, MD, acting director of the division of urology, obstetrics, and gynecology in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure. Various nonsurgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA approved specifically for this use. Today’s approval provides an FDA-approved medical treatment option for these patients.”
Fibroids, which occur most commonly in women aged 35-49 years, typically resolve after menopause but are a leading reason for hysterectomy in the United States, according to the release.
Researchers established the efficacy of the treatment in two clinical trials that included 591 premenopausal women with heavy menstrual bleeding. Participants received the drug or placebo for 6 months. The investigators defined heavy menstrual bleeding as at least two menstrual cycles with greater than 80 mL of menstrual blood loss. The primary endpoint was the proportion of women who achieved menstrual blood loss less than 80 mL at the final month and 50% or greater reduction in menstrual blood loss volume from baseline to the final month. In one trial, 69% of patients who received Oriahnn met this endpoint, compared with 9% of patients who received placebo. In the second study, 77% of patients who received the drug achieved this endpoint, compared with 11% of patients who received placebo.
Oriahnn may cause bone loss that may not be completely recovered after stopping treatment, so women should not take the medication for more than 24 months, according to the FDA announcement. Health care professionals may recommend bone density scans before and during treatment.
The most common side effects included hot flushes, headache, fatigue, and irregular vaginal bleeding. The drug’s label includes a boxed warning about a risk of strokes and blood clots, especially in women at increased risk for these events. Contraindications include osteoporosis, a history of breast cancer or other hormonally sensitive cancer, liver disease, and abnormal uterine bleeding. Oriahnn does not prevent pregnancy and may increase blood pressure, according to the press release. AbbVie markets the drug.