The First Once-Daily Treatment for Heavy Menstrual Bleeding Related to Uterine Fibroids Is Now Approved

The US Food and Drug Administration has approved myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

This is the first once-daily treatment to be approved for this indication.

The approval comes after positive results from the LIBERTY 1 and 2 studies were published. At week 24 of the trials, 72.1% of women taking myfembree in the LIBERTY 1 trial and 71.2% of women taking myfembree in the LIBERTY 2 trial responded to treatment. Comparatively, only 16.8% of women taking placebo in the LIBERTY 1 trial and 14.7% of women taking placebo in the LIBERTY 2 trial achieved responder criteria.

“Uterine fibroids affect millions of women in the US and account for over 250,000 hysterectomies each year, with heavy menstrual bleeding being one of the most bothersome symptoms,” said David Marek, chief executive officer of Myovant Sciences, Inc. “The approval of MYFEMBREE represents the second FDA product approval for Myovant in less than one year. This is an important step forward as we seek to redefine care for women and for men, not only through new medicines but through continued collaboration with the community.”

—Amanda Balbi

Reference

Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids. News release. Myovant Sciences; May 26, 2021. https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-and-pfizer-receive-fda-approval-myfembreer