FDA Approves Myfembree for Heavy Menstrual Bleeding

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.

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.