NEWS

FDA Approves Myfembree to Treat Uterine Fibroids

Myfembree

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.

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.” 

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%.

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."

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.

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.

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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.
  1. Pfizer. Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids. Published May 26, 2021.

  2. Agency for Healthcare Research and Quality. Management of uterine fibroids. Published December 2017.

  3. Myovant Sciences. Myfembree: highlights of prescribing information. Updated June 7, 2021.