Myfembree® Brings New Hope to Women with Uterine Fibroids
In May 2021, Pfizer and Myovant Sciences’ Myfembree® (relugolix, estradiol, and norethindrone acetate) became the first once-daily U.S. Food and Drug Administration (FDA) approved treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months.1 This milestone marked a critical step forward in a disease area that has previously had limited non-invasive treatment options and relied heavily on surgical procedures such as hysterectomies.2,3
An estimated five million women in the U.S. suffer from symptoms of uterine fibroids,1 which are noncancerous tumors that develop in or on the muscular walls of the uterus.4 Fibroids may cause symptoms such as heavy menstrual bleeding, which can limit women’s daily activities and impact many aspects of their lives.3
In September, continuing the momentum from the Myfembree approval for women with uterine fibroids, the FDA accepted for review a supplemental New Drug Application (sNDA) for the management of moderate to severe pain associated with endometriosis,5 an often-painful pelvic condition affecting approximately six million women in the U.S with limited treatment options.6,7
These regulatory milestones, in conditions that have historically been stigmatized and underrecognized,8,9 underscore our commitment to bringing women new options to manage their reproductive health and advancing women’s health overall.
*For full efficacy and safety information about Myfembree, please see the full prescribing information here.
Pfizer Inc. 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 December 8, 2021.
NCBI. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212348/. Published 2021. Accessed Accessed December 8, 2021.
Thieme Medical. https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0037-1607264. Published. Accessed December 8, 2021.
U.S. Department of Health & Human Services, Office on Women’s Health. https://www.womenshealth.gov/a-z-topics/uterine-fibroids. Published 2019. Accessed December 8, 2021.
Pfizer Inc. Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis. September 9, 2021. https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-announce-fda-acceptance. Accessed December 8, 2021.
Penn Medicine. Endometriosis. https://www.pennmedicine.org/for-patients-and-visitors/patient-information/conditions-treated-a-to-z/endometriosis. Published 2022. Accessed December 8, 2021.
Chemical & Engineering News. The long road to relief from endometriosis. https://cen.acs.org/pharmaceuticals/drug-development/long-road-relief-endometriosis/96/i43. Published 2018. Accessed December 8, 2021.
MDPI. Stigma and Endometriosis: A Brief Overview and Recommendations to Improve Psychosocial Well-Being and Diagnostic Delay. https://www.mdpi.com/1660-4601/18/15/8210/htm. Published 2021. Accessed December 8, 2021.
International Journal of Gynecology & Obstetrics. Epidemiology and management of uterine fibroids. https://obgyn.onlinelibrary.wiley.com/doi/full/10.1002/ijgo.13102?saml_referrer. Published 2020. Accessed December 8, 2021.