In May 2021, Pfizer and Myovant Sciences’ Myfembree® (relugolix, estradiol, and norethindrone acetate) became the first once-daily U.S. Food and Drug Administration (FDA) approved treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.¹ This milestone marked a critical step forward in a disease area that has previously had limited non-invasive treatment options and relied heavily on surgical procedures such as hysterectomies.^2,3

An estimated five million women in the U.S. suffer from symptoms of uterine fibroids,¹ which are noncancerous tumors that develop in or on the muscular walls of the uterus.⁴ Fibroids may cause symptoms such as heavy menstrual bleeding, which can limit women’s daily activities and impact many aspects of their lives.³

In September, continuing the momentum from the Myfembree approval for women with uterine fibroids, the FDA accepted for review a supplemental New Drug Application (sNDA) for the management of moderate to severe pain associated with endometriosis,⁵ an often-painful pelvic condition affecting approximately six million women in the U.S with limited treatment options.^6,7

These regulatory milestones, in conditions that have historically been stigmatized and underrecognized,^8,9 underscore our commitment to bringing women new options to manage their reproductive health and advancing women’s health overall.

*For full efficacy and safety information about Myfembree, please see the full prescribing information here.