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# Myovant, Pfizer Myfembree sNDA Review Extended
- URL: https://www.fdaweb.com/myovant-pfizer-myfembree-snda-review-extended/
- Published: 2022-05-06T12:00:00.000Z
- Updated: 2026-09-14T17:43:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151760

FDA has extended by three months its review of 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. FDA told the companies that it requires additional time to review information it requested from the companies regarding bone mineral density. Last month, they said FDA told them that it found deficiencies in the submission, which precluded discussions on labeling and/or post-marketing requirements and commitments at that time. The agency has now revised the user fee review action target date to 8/6.

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, according to the companies.

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.