WASHINGTON -- A to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
To be sold as Oriahnn and made by AbbVie, the product includes elagolix, estradiol and norethindrone acetate capsules co-packaged for convenience. It's the first non-surgical therapy approved by the FDA specifically for this purpose, the agency said.
Approval comes after two clinical trials, in which nearly 600 premenopausal women with heavy menstrual bleeding from uterine fibroids received Oriahnn or a placebo for six months.
In both trials, more women that received the drug achieved at least two menstrual cycles with less than 80 mL of blood loss and a 50% reduction in menstrual blood volume from the study's start to end (69% vs 9% in the placebo group, and 77% vs 11%, respectively).
Fibroids are non-cancerous muscle tumors in the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems or infertility. They are most common in women between ages 35 to 49.
In an agency statement, Christine Nguyen, MD, of the FDA's Center for Drug Evaluation and Research, said that "uterine fibroids are the most common benign tumors affecting premenopausal women." Hysterectomy and other surgical treatments are an option to treat heavy fibroid-related bleeding, but patients may prefer non-surgical routes.
Oriahnn may cause permanent bone loss, and it poses a risk for fractures later in life. Women should not take the drug for more than 24 months, and some providers may recommend a DXA scan to monitor bone density during treatment.
The drug was approved with a boxed warning about risk of strokes and blood clots. Oriahnn is contraindicated in women with a history of blood clots, uncontrolled hypertension or those over age 35 who smoke. Other contraindications include osteoporosis, breast cancer or other hormone-sensitive cancers, liver disease, or undiagnosed abnormal uterine bleeding.
Side effects include hot flushes, headaches, fatigue and irregular vaginal bleeding.
Oriahnn is not a form of contraception, and the FDA recommends that women use non-hormonal birth control methods during treatment and one week after discontinuing the medication.