FDA Expands Approval of Pfizer and Myovant’s Myfembree to Include Endometriosis

August 10, 2022

The FDA has expanded its approval of Pfizer and Myovant’s oral drug Myfembree (relugolix, estradiol and norethindrone acetate) to include the management of moderate-to-severe pain associated with endometriosis in premenopausal women, with a treatment duration of up to 24 months.

The drug combines relugolix, a gonadotropin-releasing hormone receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin.

The expanded approval was based on one-year data from late-stage studies showing that Myfembree reduced menstrual pain and non-menstrual pelvic pain with a loss of mean bone mineral density of less than one percent through one year of treatment.

Myfembree is also approved for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

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