Myfembree approved for heavy menstrual bleeding associated with uterine fibroids

Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have announced that the US Food and Drug Administration (FDA) has approved Myfembree (relugolix/estradiol/norethindrone acetate), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.

Under the terms of their previously announced collaboration, Myovant and Pfizer will jointly commercialize the product in the USA. The tablet is expected to be available next month.

"The approval of Myfembree represents the second FDA product approval for Myovant in less than one year"Ayman Al-Hendy, professor of obstetrics and gynecology, University of Chicago, and LIBERTY Program steering committee member, said: “With Myfembree, we can offer women with uterine fibroids a non-invasive treatment that provides clinically-meaningful symptom relief for heavy menstrual bleeding with one pill, once-a-day.