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28 May 2021

Insight on US FDA approval of Myfembree OD treatment for management of heavy menstrual bleeding associated with uterine fibroids

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Myovant Sciences and Pfizer announced that the US Food and Drug Administration (FDA) has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), 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. The approval is supported by efficacy and safety data from the phase 3 LIBERTY 1 and LIBERTY 2 studies, which were published in the New England Journal of Medicine. Under the terms of their previously announced collaboration, Myovant and Pfizer will jointly commercialize Myfembree in the US Myfembree is expected to be available in June 2021.

Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women.

Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is the first once-daily treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the US Food and Drug Administration, with treatment duration of up to 24 months. Myfembree contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

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