The Food and Drug Administration (FDA) has approved Oriahnn™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules; AbbVie) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Oriahnn consists of 2 capsules: a morning capsule that contains elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist (300mg), estradiol, an estrogen (1mg), and norethindrone acetate, a progestin (0.5mg), and an evening capsule that contains elagolix 300mg.
Administration of elagolix reduces bleeding associated with uterine fibroids by suppressing luteinizing hormone and follicle-stimulating hormone, leading to decreased blood concentrations of estradiol and progesterone. As a component of Oriahnn, the addition of estradiol may reduce the increase in bone resorption and resultant bone loss that can occur due to a decrease in circulating estrogen from elagolix alone, while norethindrone acetate may protect the uterus from the potential adverse endometrial effects of unopposed estrogen.
The approval was based on data from 2 double-blind, placebo-controlled studies in which 790 premenopausal women with heavy menstrual bleeding received Oriahnn or placebo for 6 months. The primary end point of both studies was the proportion of responders, defined as women who achieved both menstrual blood loss volume less than 80mL at the final month (the last 28 days before and including the last treatment visit date or the last dose date) and ≥50% reduction in menstrual blood loss volume from baseline to the final month.
Results showed a higher proportion of women treated with Oriahnn were responders compared with placebo. In Study 1, 68.5% of Oriahnn-treated patients were responders compared with 8.7% of the placebo arm (treatment difference: 59.8% [95% CI, 51.1-68.5]; P <.001). In addition, the mean reduction of menstrual blood loss volume from baseline to final month was -177mL for Oriahnn and 1mL for placebo.
In Study 2, 76.5% of patients who received Oriahnn were responders vs 10.5% of placebo-treated patients (treatment difference: 66.0% [95% CI, 57.1-75.0]; P <.001). Mean reduction of menstrual blood loss volume from baseline to final month was -169mL and -4mL, respectively.
In both studies, a greater proportion of women receiving Oriahnn experienced suppression of bleeding at final month, compared with placebo. Among women who were anemic with baseline hemoglobin (Hgb) ≤10.5g/dL, a greater proportion of of Oriahnn-treated patients achieved an increase of >2g/dL in Hgb from baseline to month 6, compared with placebo-treated women.
With regard to safety, the most common adverse reactions reported included hot flushes, headache, fatigue, and metrorrhagia. Use of Oriahnn should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.
“Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use,” said Christine P. Nguyen, MD, Acting Director, Division of Urology, Obstetrics and Gynecology in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an FDA-approved medical treatment option for these patients”
Oriahnn will be supplied in weekly blister packs. Each blister pack contains 7 AM capsules and 7 PM capsules, with 4 blisters packaged into a carton. The product is expected to be available by the end of June 2020.
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