This site is intended for healthcare professionals
News

FDA Approval of Myfembree, a once-daily treatment for the management of moderate to severe pain associated with endometriosis.- Pfizer + Myovant Sciences

Read time: 1 mins
Published:6th Aug 2022

Myovant Sciences and Pfizer Inc. announced that the FDA)has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.

 

The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase III SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet, and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. Myfembree also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize Myfembree in the U.S. and product is available immediately..

Condition: Pain; Endometriosis
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.