News
Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids.
Myovant Sciences and Pfizer Inc. announced that the 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 III 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 U.S. Myfembree is expected to be available in June 2021.
Condition: Uterine Fibroids
Type: drug
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