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# FDA Approves Myfembree for Heavy Menstrual Bleeding
- URL: https://www.fdaweb.com/fda-approves-myfembree-for-heavy-menstrual-bleeding/
- Published: 2021-05-26T12:00:00.000Z
- Updated: 2026-09-14T17:00:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149413

FDA has approved a Myovant Sciences and Pfizer NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Approval was based on data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies, which were published in the [*New England Journal of Medicine*](https://www.globenewswire.com/Tracker?data=UjWGCm4lF%5FlZ%5FAcrL7Odw5Q7Ld8Vvv2f41QVV9UdnZ73jGI0fiP9PZ7a1ypBno44e%5FNPsAsL7CYo9EZWus9gXoHQlkt7zlqqJvos%5Fwl-HodYS-xw1f9ONkDZGOWMuw-JHDjkIpUiclk44rM3cdRdqg==&ref=fdaweb.com).

The studies each met the primary endpoint, with 72.1% and 71.2% of women in the Myfembree groups achieving the responder criteria compared with 16.8% and 14.7% of women in the placebo groups at Week 24, respectively, the companies say. “A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method,” they say.