Myfembree FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 8, 2022.
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, Endometriosis
Myfembree (relugolix, estradiol and norethindrone acetate) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen, and progestin combination indicated in premenopausal women for the management of heavy menstrual bleeding associated with uterine fibroids, and moderate to severe pain associated with endometriosis.
- The gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix works to reduce 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 in women with heavy menstrual bleeding associated with uterine fibroids include hot flashes, increased sweating, night sweats, abnormal uterine bleeding, alopecia, and decreased libido. Common adverse reactions in women with moderate to severe pain associated with endometriosis include headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.
Development timeline for Myfembree
| Date | Article |
|---|
| Aug 5, 2022 | Approval Myovant Sciences and Pfizer Receive U.S. FDA Approval of Myfembree, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis |
| May 26, 2021 | Approval FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| Apr 12, 2021 | Myovant Sciences and Pfizer Announce First Participant Dosed in Phase 3 SERENE Study Evaluating Contraceptive Efficacy of Once-Daily Relugolix Combination Tablet |
| Mar 24, 2021 | Myovant 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, 2021 | Myovant 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, 2020 | Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Studies in Endometriosis and Uterine Fibroids |
| Aug 17, 2020 | Myovant Sciences Announces FDA Acceptance of New Drug Application for Once-Daily Relugolix Combination Tablet for Uterine Fibroids |
| Jul 6, 2020 | Myovant 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, 2020 | Myovant Sciences Announces Positive Results from Second Phase 3 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis |
| Jun 1, 2020 | Sumitovant 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, 2020 | Myovant 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, 2019 | Myovant Sciences Announces Positive Phase 3 Results from LIBERTY 1 Study Evaluating Once Daily Relugolix Combination Therapy in Women with Uterine Fibroids |
| Jun 29, 2017 | Myovant Sciences Initiates Phase 3 Clinical Program of Relugolix in Women with Endometriosis-Associated Pain |
Further information
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