FDA Approves Pfizer and Myovant's MYFEMBREE for Uterine Fibroids

The U.S. Food and Drug Administration (FDA) has approved a new treatment for women experiencing heavy menstrual bleeding due to uterine fibroids. Pfizer Inc. and Myovant Sciences announced the approval in May 2021. The medication, MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), is the first once-daily oral therapy for managing this condition.

The approval is based on efficacy and safety data from two Phase 3 studies, LIBERTY 1 and LIBERTY 2. In these trials, MYFEMBREE demonstrated a significant reduction in menstrual blood loss. The treatment resulted in an average reduction of over 80% in menstrual blood loss from baseline over a 24-month treatment duration, showing statistically significant improvement compared to placebo.

Uterine fibroids are noncancerous tumors that are common in women and can cause symptoms such as heavy and painful periods. They can lead to anemia and significantly impact women's quality of life. In the U.S., uterine fibroids lead to over 250,000 hysterectomies annually.

Myovant and Pfizer have a collaboration agreement to co-commercialize MYFEMBREE in the U.S. The medication was expected to be available in June 2021. The companies also offer patient support programs to facilitate access and use of the medication, including assistance with insurance benefits and co-pay support.