– Uterine fibroids are the most common type of benign tumor in women of reproductive age[1]
– ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is expected to be available in the U.S. by the end of June 2020
NORTH CHICAGO, IL, USA I May 29, 2020 I AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months.2 ORIAHNN is the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.2 ORIAHNN is expected to be available in the U.S. by the end of June 2020.
“Women who experience heavy menstrual bleeding as a symptom not only deal with the physical toll of uterine fibroids, but also the burdens surrounding its management while trying to get through with their day-to-day routines,” said Ayman Al-Hendy, M.D., Ph.D., investigator for the ELARIS UF-2 clinical trials, and professor of gynecology and director of translational research at the University of Illinois at Chicago. “This approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way.”
Uterine fibroids, also called leiomyomas, are estrogen and progesterone-dependent non-cancerous tumors of the uterus and are the most common type of benign tumor in women of reproductive age, affecting up to 70 percent of Caucasian women and up to 80 percent of African American women by age 50.1,3,4,5,6,7 Traditionally, uterine fibroids have been primarily managed by surgery and are the leading reason for the hysterectomies performed in the U.S.1,3,5,8
“It is always deeply rewarding when the years of development our researchers and scientists dedicate to creating a new way to treat patients is successful,” said Michael Severino, M.D., vice chairman and president, AbbVie. “ORIAHNN signifies an important advance in how we can care for women with uterine fibroids.”
In the two, randomized Phase 3 uterine fibroid clinical trials, ELARIS UF-I and ELARIS UF-II, ORIAHNN achieved the primary endpoint of clinically meaningful reduction in bleeding (defined as the proportion of women who achieved both at least a 50 percent reduction in menstrual blood loss at final month of treatment and a total menstrual blood loss amount of less than 80 ml), compared with placebo in final month of study for patients, with seven out of 10 women no longer experiencing heavy menstrual bleeding versus one out of 10 women on placebo (P<0.001 for both trials).9 ORIAHNN also reduced heavy menstrual bleeding due to uterine fibroids by 50 percent within the first month of use.9 The results from these studies were recently published in The New England Journal of Medicine.
ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are a smoker over 35 years of age with high blood pressure.2 Please see the important safety information below for more information. ORIAHNN is taken twice daily (morning and evening) at approximately the same time each day, with or without food. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.2
“We have heard from women with fibroids across the country who have been hopeful for a treatment with the potential to address their bleeding effectively,” said Jenny Rosenberg, executive director of CARE About Fibroids. “The FDA’s approval of an oral treatment for women suffering from heavy menstrual bleeding due to uterine fibroids marks a step forward in women’s health.”10
About Uterine Fibroids
Uterine fibroids (also called leiomyomas or myomas) are non-cancerous, hormonally-responsive muscle tissue tumors of the uterus.1,3 Fibroids are the most common type of abnormal growth in a woman’s pelvis and can affect up to 70 percent of Caucasian women and up to 80 of African American women by age 50.1,3,4,5,6,7 Fibroids can range in size, shape, number and location.5 Fibroids can be asymptomatic but, in some women, they can cause symptoms such as heavy menstrual bleeding.3,4,5 Treatment options for uterine fibroids include surgery (hysterectomy, myomectomy), endometrial ablation, uterine artery embolization, magnetic resonance imaging (MRI)-guided focused ultrasound and medical management with treatments such as oral contraceptives, progestins, selective progesterone receptor modulators, and gonadotropin-releasing hormone (GnRH) agonists and antagonists.1,9
About ORIAHNNTM (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules)
ORIAHNN is approved by the U.S. Food and Drug Administration (FDA) as an oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women.2 ORIAHNN is an oral combination of elagolix and E2/NETA (estradiol/norethindrone acetate) to help achieve a balance between the reduction of heavy bleeding and associated hypoestrogenic side effects.2
The full U.S. prescribing information, including the medication guide, for ORIAHNN can be found on rxabbvie.com.
USE
ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
1 De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95(2):100-107.
2 ORIAHNN™ (elagolix, estradiol and norethindrone acetate capsules co-formulated) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
3 Office on Women’s Health, WomensHealth.gov. Uterine Fibroids. https://www.womenshealth.gov/a-z-topics/uterine-fibroids.
4 Khan A et al. Uterine fibroids: current perspectives. Int J Women’s Health. 2014;6:95-114.
5 The American College of Obstetricians and Gynecologists: FAQ Uterine Fibroids. https://www.acog.org/patient-resources/faqs/gynecologic-problems/uterine-fibroids.
6 Wallach EE et al. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol. 2004;104:393–406.
7 Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2013;188:100-107.
8 Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin No. 96. American College of Obstetricians and Gynecologist. Obstet Gynecol 2008; 112:387-400.
9 Data on file.
10 Reference to CARE About Fibroids reflects their recognition of the need for medical management options for this patient population, but is not meant to be an endorsement or recommendation of use by this organization of ORIAHNN or AbbVie.
SOURCE: AbbVie
