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Myfembree FDA Approval History

Last updated by Judith Stewart, BPharm on June 2, 2021.

FDA Approved: Yes (First approved May 26, 2021)
Brand name: Myfembree
Generic name: relugolix, estradiol and norethindrone acetate
Dosage form: Tablets
Company: Myovant Sciences
Treatment for: Uterine Fibroids

Myfembree (relugolix, estradiol and norethindrone acetate) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen, and progestin combination indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

  • The gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix works to reduce the growth of uterine fibroids by reducing ovarian estradiol production. Adding low doses of estradiol in combination with relugolix can offset the side effects of low-estrogen levels including bone loss and hot flashes. Progestins are necessary whenever a woman with a uterus takes estrogen.
  • Myfembree use should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.
  • Myfembree tablets are taken once daily.
  • The Myfembree product label carries a boxed warning for thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events. Common adverse reactions include hot flashes, increased sweating, night sweats, abnormal uterine bleeding, alopecia, and decreased libido.

Development timeline for Myfembree

DateArticle
May 26, 2021Approval  FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids
Apr 12, 2021Myovant Sciences and Pfizer Announce First Participant Dosed in Phase 3 SERENE Study Evaluating Contraceptive Efficacy of Once-Daily Relugolix Combination Tablet
Mar 24, 2021Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids
Jan 26, 2021Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis
Oct 21, 2020Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Studies in Endometriosis and Uterine Fibroids
Aug 17, 2020Myovant Sciences Announces FDA Acceptance of New Drug Application for Once-Daily Relugolix Combination Tablet for Uterine Fibroids
Jul  6, 2020Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Phase 3 LIBERTY Studies in Women with Uterine Fibroids and from Ovulation Inhibition Study
Jun 23, 2020Myovant Sciences Announces Positive Results from Second Phase 3 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis
Jun  1, 2020Sumitovant Biopharma Announces Myovant Sciences’ Submission of New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids
Jun  1, 2020Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids
May 14, 2019Myovant Sciences Announces Positive Phase 3 Results from LIBERTY 1 Study Evaluating Once Daily Relugolix Combination Therapy in Women with Uterine Fibroids
Jun 29, 2017Myovant Sciences Initiates Phase 3 Clinical Program of Relugolix in Women with Endometriosis-Associated Pain

Further information

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