16 Jun FDA Approves ORIAHNN™ : First Oral Medication for Heavy Menstrual Bleeding Due to Uterine Fibroids
MedicalResearch.com Interview with:
Ayman Al-Hendy, M.D., Ph.D.
Investigator for the ELARIS UF-2 clinical trials
Professor of Gynecology
Director of Translational Research
University of Illinois at Chicago
Dr. Al-Hendy discusses the recent announcement that the FDA has approved ORIAHNN™ for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women.
MedicalResearch.com: What is the background for this approval?
Uterine fibroids, commonly referred to as uterine leiomyomas, are the most common type of non-cancerous tumor known to impact women of reproductive age (30-50 years old). In fact, studies show that uterine fibroids can occur in up to 70 percent of European American women and over 80 percent of African American women by age 50. As a result of uterine fibroids, women can experience a range of symptoms, the most common being heavy menstrual bleeding (i.e. prolonged and/or frequent bleeding), which can lead to other health effects such as anemia, fatigue, pelvic pain, urinary frequency etc.
Uterine fibroid treatment recommendations have historically been based on the size and location of the fibroid(s). When treating larger and more complicated fibroids, healthcare providers have typically believed that surgery is their best course of action, which has made uterine fibroids the leading reason for the hysterectomies performed in the U.S. The FDA approval of ORIAHNN was based on improving care for uterine fibroid sufferers who have had a negative impact on their quality of life due to disruptive symptoms. What makes the approval of ORIAHNN so exciting, is that women now have an oral therapy to directly address heavy menstrual bleeding due to uterine fibroids.
MedicalResearch.com: How does ORIAHNN differ from other medications for uterine bleeding from fibroids?
Response: Prior to the FDA approval of ORIAHNN, a healthcare provider may first recommend a non-invasive medical treatment, such as oral contraceptives, progestins etc., to alleviate uterine fibroid related symptoms, primarily heavy menstrual bleeding. These options typically make the lining of the uterus, called the endometrium, thin to help decrease menstrual bleeding to a manageable level. However, not all patients are the same and this form of treatment may not be effective in decreasing heavy bleeding. If/when medical management no longer works for a patient, we think through surgical options including hysterectomy and myomectomy, but both are major surgical interventions which come with potential complications and risks. ORIAHNN is quite different, it is the first FDA-approved non-surgical oral therapy that addresses uterine fibroids directly by almost shutting down the ovarian hormonal function and decreasing the amount of estrogen and progestin being produced by the ovaries, essentially depriving fibroids of their lifeline.
MedicalResearch.com: What are the main findings of the clinical trials supporting this approval?
Response: This FDA approval is based on two identical, double-blind, randomized, placebo-controlled, 6-month Phase 3 trials, ELARIS UF-I and ELARIS UF-II, made up of women with moderate to severe heavy menstrual bleeding. 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 the final month of study for patients, with seven out of 10 women no longer experiencing heavy menstrual bleeding, compared with one out of 10 women on placebo. ORIAHNN also reduced heavy menstrual bleeding due to uterine fibroids by 50 percent within the first month of use. The results from these studies were published in January 2020 in The New England Journal of Medicine.
MedicalResearch.com: What should readers take away from these trials?
Response: In these studies, women experiencing heavy menstrual bleeding associated with uterine fibroids who were treated with ORIAHNN reported the severity of their uterine fibroids symptoms was reduced and their health-related quality of life improved. Furthermore, additional data has shown that women treated with ORIAHNN were able to experience the same efficacy and safety results for their symptoms, regardless of factors such as primary fibroid volume, fibroid location within the uterus, and uterine volume. As a result of these trials and subsequent FDA approval, women and their healthcare providers now have a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way.
MedicalResearch.com: Is there anything else you would like to add?
Response: As a gynecologist, I am very excited about this new therapy because many of my patients have previously undergone surgery due to lack of treatment options. It’s exciting that we now have ORIAHNN as a non-surgical, oral medication option to discuss with my patients who experience heavy menstrual bleeding associated with uterine fibroids. This approval signifies a very important tool for uterine fibroid care and the future of women’s health. It is my hope that uterine fibroids can soon be managed medically with surgery only being used when absolutely necessary.
Disclosures: Dr. Al-Hendy is a paid consultant for AbbVie.
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