Treatment approved for heavy menstrual bleeding associated with fibroids

Abstract

Oriahnn (AbbVie) is the first and only FDA-approved oral treatment for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. The treatment is a combination capsule containing elagolix 300 mg, estradiol 1 mg, and norethindrone 0.5 mg for the morning dose copackaged with a capsule of elagolix 300 mg for the evening dose. Uterine fibroids, common benign tumors in premenopausal women, can have a significant impact on quality of life, with symptoms such as heavy menstrual bleeding, pain, and bowel and bladder issues. Treatment options have included various surgical procedures such as hysterectomy and myomectomy, and medical therapies to reduce heavy menstrual bleeding (e.g., hormonal contraceptives, tranexamic acid, and NSAIDs). “Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure,” said Christine P. Nguyen, MD, acting director, division of Urology, Obstetrics and Gynecology in FDA’s Center for Drug Evaluation and Research in an FDA news release. She noted that “various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use.” The approval of Oriahnn now offers patients a nonsurgical option to help manage their condition. Uterine fibroids can be detected in up to 80% of women by the age of 50. Their growth is dependent on estrogen and progesterone, with the prevalence of fibroids increasing during a woman’s reproductive years. Race has also been identified as a risk factor for uterine fibroids, with Black women having a higher lifetime prevalence of fibroids and more severe symptoms compared with white women. Although some women may be asymptomatic, it is estimated that 20% to 50% of women seek either surgical or nonsurgical treatment to manage their symptoms. Oriahnn contains a gonadotropin-releasing hormone receptor antagonist (elagolix 300 mg), an estrogen (estradiol 1 mg), and a progestin (norethindrone acetate 0.5 mg). The elagolix results in a dose-dependent suppression of luteinizing hormone and follicle-stimulating hormone, leading to decreased concentrations of estradiol and progesterone and reduced bleeding associated with the uterine fibroids. The inclusion of estradiol and norethindrone in the morning dose helps achieve a balance between the reduction of heavy menstrual bleeding and associated hypoestrogenic adverse effects. The labeling states that the estradiol may reduce the bone loss that may occur with the reduction in estrogen levels from the elagolix, and the norethindrone may work to protect the uterus from the potential adverse endometrial effects from unopposed estrogen. The treatment may be given for up to 24 months. Approval was based on data from two randomized Phase III trials that evaluated data from 591 premenopausal women with heavy menstrual bleeding who were treated with elagolix 300 mg, estradiol 1 mg, and norethindrone 0.5 mg in the morning and elagolix 300 mg in the evening or placebo for 6 months. In both trials, more women who received the active treatment had reductions in menstrual blood loss compared with placebo from baseline to the final month of treatment. The most common adverse effects with Oriahnn from the clinical trials were hot flushes, headache, fatigue, and irregular vaginal bleeding. Numerous warnings and precautions are also listed in the label, with bone loss being one of them because of duration-dependent decreases in bone mineral density that may occur due to low estrogen levels. This effect may not be reversible and is the reason for limiting treatment to 24 months. Other warnings and precautions include thromboembolic disorders and vascular events, mood disorders, elevated blood pressure, and changes in menstrual bleeding patterns and the reduced ability to recognize pregnancy. Women should be counseled to use nonhormonal contraception while receiving treatment and for one week after discontinuing the drug.