Myfembree sNDA for Endometriosis Pain

FDA has accepted for review a Myovant Sciences and Pfizer supplemental NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. The agency set a user fee review action target date of 5/6/2022.

The submission is based on data from the Phase 3 SPIRIT program, which included two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) in over 1,200 women with pain associated with endometriosis for 24 weeks, and an open-label extension study for eligible women through one year.

Endometriosis is an estrogen-dependent, inflammatory disease in which tissue similar to the uterine lining is found outside the uterine cavity, which results in chronic inflammation and can cause scarring and adhesions.

Myfembree is currently approved for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.