MYFEMBREE® Offers a Treatment Option in Two Woman’s Health Conditions
On August 5, 2022, Pfizer and Myovant Sciences’ MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) was approved by the U.S. Food and Drug Administration (FDA) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in premenopausal women, with a treatment duration of up to 24 months.1 Approval was supported by data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which showed a reduction in dysmenorrhea and non-menstrual pelvic pain versus placebo at week 24. Adverse reactions occurring in at least 3% of women treated with MYFEMBREE and greater than placebo were: headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.2
This additional indication for MYFEMBREE underscores Pfizer and Myovant’s commitment to addressing areas of significant unmet need in women’s health.
In the U.S., there are approximately 7.5 million premenopausal women with endometriosis and approximately 75-80% of them are symptomatic.3,4,5,6 Many women who experience endometriosis associated-pain are not able to manage their symptoms with current treatment options, highlighting the high unmet need for this disease.7 It can take between four and eleven years to get an endometriosis diagnosis,8,9,10 and for some women, current treatment options do not provide relief.11
This approval builds on the momentum from 2021’s approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. It also marks an important milestone in our mission to address women’s health needs that are often overlooked by expanding treatment options for these conditions, which can be debilitating.
*For full efficacy and safety information about MYFEMBREE, please see the full prescribing information here.
- Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids. May 26, 2021. https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-receive-fda-approval-myfembreer. Accessed October 31, 2022.
- 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 August 05, 2022. https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-receive-us-fda-approval#:~:text=MYFEMBREE%20(relugolix%2C%20 estradiol%2C%20and,of%20up%20to%2024%20months). Accessed October 31, 2022.
- US census 2019 (table 1; approx. 75 million women in the US ages 15-49). Available online at https://data.census.gov/cedsci/table?q=United%20States&t=Age%20and%20Sex Accessed October 31, 2022.
- Shafrir. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:1-15 Accessed October 31, 2022.
- Fuldeore Gynecol Obstet Invest. 2017;82:453-461 Accessed October 31, 2022.
- Bulletti J Asist Reprod Genet 2010 Accessed October 31, 2022.
- Becker CM, et al. Fertil Steril. 2017 Jul;108(1):125-136. Accessed October 31, 2022.
- Zondervan KT, et al. NEJM. 2020;382(13):1244–1256 Accessed October 31, 2022.
- Nnoaham KE et al. Fertil Steril. 2011;96(2):366.e8–373.e8 Accessed October 31, 2022.
- Ballard K et al. Fertil Steril. 2006;86:1296–301 Accessed October 31, 2022.
- Soliman et al. J Women’s Health. 2017. 26(7): 788-797 Accessed October 31, 2022.
