This is the first non-surgical option approved by the FDA to treat fibroid-related heavy menstrual bleeding.
The US Food and Drug Administration (FDA) today approved Oriahnn capsules, an estrogen and progestin combination product, to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Oriahnn capsules consist of elagolix, estradiol, and norethindrone acetate. The capsules are co-packaged for oral use.
Uterine fibroids are the most common tumors affecting premenopausal women, said Christine Nguyen, MD, said.
Fibroids are benign muscle tumors of the uterus that could cause heavy menstrual bleeding, pain, bowel or bladder problems, and infertility. They typically resolve after menopause but are the leading reason for a hysterectomy.
“Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use,” Nguyen, Acting Director of the Division of Urology, Obstetrics, and Gynecology in FDA’s Center for Drug Evaluation and Research, said in a statement. “Today’s approval provides an FDA-approved medical treatment option for these patients.”
The approval comes following 2 clinical trials 591 total premenopausal women with heavy menstrual bleeding. The women were given the drug or placebo for 6 months. Investigators defined heavy menstrual bleeding at baseline as having >2 menstrual cycles with >80 mL of menstrual blood loss.
During the investigation, the primary endpoint was the proportion of women who achieved menstrual blood loss volume <80 mL at the final month. Another main endpoint was 50% or greater reduction in menstrual blood loss from the start of the study to the final month.
In the first study, 68.5% of those who took Oriahnn achieved the endpoint compared to 8.7% of patients who received placebo. In trial 2, 76.5% of patients who received the drug achieved the endpoint compared to 10.5% of patients who received placebo.
The most common side effects included hot flushes, headache, fatigue, and irregular vaginal bleeding. The drug label includes a Boxed Warning about the risk of vascular events and thrombotic or thromboembolic disorders.