Pfizer Inc. and Myovant Sciences announced that the U.S. Food and Drug Administration has approved Myfembree, the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids.
Under the collaboration terms, Myovant and Pfizer will jointly commercialize Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) in the U.S. The drug is expected to be available in June 2021.
Myfembree is approved for management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus. It is a chronic and debilitating disease for many women in the U.S.
Myfembree contains relugolix, which reduces the amount of estrogen produced by ovaries, estradiol which may reduce the risk of bone loss, and norethindrone acetate which is necessary when women with a uterus take estrogen.
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.
David Marek, Chief Executive Officer of Myovant Sciences, said, "Uterine fibroids affect millions of women in the U.S. and account for over 250,000 hysterectomies each year, with heavy menstrual bleeding being one of the most bothersome symptoms. The approval of MYFEMBREE represents the second FDA product approval for Myovant in less than one year."
The companies offer Myfembree Support Program, which provides services, including insurance benefits checks, prior authorization support, co-pay support for commercially insured patients, and patient assistance for qualifying uninsured patients.
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