NEWS Health News FDA Approves Myfembree to Treat Uterine Fibroids By Kayla Hui, MPH Kayla Hui, MPH LinkedIn Twitter Kayla Hui, MPH is the health and wellness commerce writer at Dotdash Meredith. She writes for Verywell Health. Learn about our editorial process Updated on June 23, 2021 Fact checked Verywell Health content is rigorously reviewed by a team of qualified and experienced fact checkers. Fact checkers review articles for factual accuracy, relevance, and timeliness. We rely on the most current and reputable sources, which are cited in the text and listed at the bottom of each article. Content is fact checked after it has been edited and before publication. Learn more. by Nick Blackmer Fact checked by Nick Blackmer LinkedIn Nick Blackmer is a librarian, fact-checker, and researcher with more than 20 years’ experience in consumer-oriented health and wellness content. Learn about our editorial process Share Tweet Email Print Myovant Sciences Key Takeaways Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus. Myovant Sciences and Pfizer launch Myfembree, the only once-daily treatment available for people with fibroids. Myfembree was approved by the FDA on May 26, 2021, and is currently available in the United States. On May 26, 2021, the Food and Drug Administration (FDA) approved Myfembree as the first once-daily treatment for heavy menstrual bleeding that is associated with uterine fibroids. As of June 17, 2021, the medication is available to patients in the U.S. with a physician's referral. Uterine fibroids do not always cause symptoms. When they do, the heavy bleeding and pelvic pain that they can cause can greatly affect a person's quality of life. Experts say that Myfembree could be life-changing for people who have had only limited and invasive options for treatment. An estimated 26 million women between the ages of 15 and 50 have uterine fibroids. What Causes Uterine Fibroids? A Game Changer In July 2013, Tanika Gray Valbrun, the founder of The White Dress Project, experienced heavy bleeding and pain. When she went to her doctor, they discovered that she had 27 uterine fibroids (noncancerous tumors that develop in the walls of the uterus). The tumors were wreaking havoc on her body, so Valbrun had to have a myomectomy to surgically remove the fibroids from her uterus. “It was the first time I was ever having surgery at all and the recovery was horrible,” Valbrun tells Verywell. “I had all 27 fibroids removed.” After experiencing such an invasive and complex procedure, Valbrun says that a treatment like Myfembree could be a game-changer. “I’m really happy about the introduction of this drug and the fact that women have options, because a lot of times with uterine fibroids, we haven’t been given options to manage the symptoms,” says Valbrun. “Symptoms are really what has the greatest impact on your quality of life.” More People Are Turning to the Emergency Room for Fibroid Care How Myfembree Could Help Myfembree is a pill that contains a gonadotropin-releasing hormone antagonist (relugolix), estradiol (E2), and norethindrone acetate (NETA), which work together to help stop heavy menstrual bleeding. Tanika Gray Valbrun Symptoms are really what has the greatest impact on your quality of life. — Tanika Gray Valbrun In Myovant Sciences' studies on the effectiveness of Myfembree, they assessed the response rate in the women included in the study. The response was defined as a menstrual blood loss volume of fewer than 80 milliliters and a 50% reduction in menstrual blood loss volume during the last 35 days of treatment. In the studies, Myfembree demonstrated 72.1% and 71.2% response rates in menstrual blood loss at the 24th-week mark compared to 16.8% and 14.7% of women in the placebo group. The women who received Myfembree experienced reductions in menstrual blood loss of 82% and 84.3%. Symptoms of Uterine Fibroids Why New Treatments Are Needed It is estimated that three million women are inadequately treated by current medical interventions for uterine fibroids. Ayman Al-Hendy, MD, PhD Many women are suffering in silence due to the social stigma that surrounds menstruation and talking about periods. — Ayman Al-Hendy, MD, PhD Ayman Al-Hendy, MD, PhD, professor in the Department of Obstetrics and Gynecology at the University of Chicago and clinical scientist and practicing OB/GYN, tells Verywell that Myfembree would allow people with fibroids who have not had success with current treatments to better manage their fibroids and overall health. “Many women are suffering in silence due to the social stigma that surrounds menstruation and talking about periods or thinking that major surgery is the only treatment option,” says Al-Hendy. Uterine fibroids account for over 250,000 hysterectomies each year. After discovering how many fibroids she had, Valbrun's doctors considered her uterus to be compromised and suggested a hysterectomy. “I felt very devastated, " says Valbrun. "It’s not what you want to hear, especially when you think of doing life the way you’re supposed to do it, go to school, get a good job, then get married and have babies." Can Fibroids Cause Infertility? Al-Hendy says that while treatments have been available for fibroids, they have been invasive with little to no non-invasive treatment options available and that the approval of a once-daily pill "represents a significant milestone in expanding treatment options for this burdensome condition." Raising Awareness Valbrun thought she was the only one experiencing heavy bleeding, and she says that she found herself asking, "How many women who I know are secretly dealing with this?” With a mission to raise awareness of fibroids, Valbrun started a nonprofit organization called The White Dress Project, which is based in Atlanta, Georgia. The organization’s mission is to raise global awareness about uterine fibroids through education, research, community, and advocacy. What to Know About Heavy Menstrual Bleeding Valbrun hopes that The White Dress Project will catalyze conversations about fibroids and empower people with fibroids to advocate for the treatment that works best for them. She says that the organization is "intentional about making sure that women know they have to be their own best health advocate." Myfembree is available as of June 17, but Valbrun encourages people with fibroids to talk to their doctors and bring up any questions they have about treatment options to ensure that they get the treatment that will work best for them. Al-Hendy adds that “Myfembree has the potential to provide much-needed symptom relief with the convenience of an oral, once-daily tablet," and that "it’s an important step forward in a disease area that has historically relied heavily on invasive procedures.” What This Means For You If you have uterine fibroids or experiencing heavy bleeding that you are concerned could be caused by fibroids, talk to your doctor about your treatment options. You might be able to get a referral for a new once-daily treatment, Myfembree, which was just approved by the FDA. Uterine Fibroids in Black Women Was this page helpful? Thanks for your feedback! Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit 3 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Pfizer. Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids. Agency for Healthcare Research and Quality. Management of uterine fibroids. Myovant Sciences. Myfembree: highlights of prescribing information.