Clinical Myovant Sciences and Pfizer get the FDA nod on...

Myovant Sciences and Pfizer get the FDA nod on MYFEMBREE® to treat heavy menstrual bleeding with once a day treatment


The United States FDA ( Food and Drug Administration) has authorized MYFEMBREE ( relugolix 40mg, estradiol 1mg, norethindrone acetate 0.5mg), which is used for the treatment of heavy menstrual bleeding due to uterine fibroids in premenopausal females and is taken once daily by mouth for up to 24 months, according to Pfizer and Myovant Sciences. This authorization is based on the safety and efficacy results which were published in the New England Journal of Medicine from the phase-llI LIBERTY 1&2 trials. Pfizer and Myovant will market MYFEMBREE together in the United States, as per the terms of their agreement. MYFEMBREE is scheduled to launch in June 2021.

“With MYFEMBREE, we can offer women with uterine fibroids a non-invasive treatment that provides clinically meaningful symptom relief for heavy menstrual bleeding with one pill, once-a-day,” said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago, and LIBERTY Program Steering Committee Member. “The FDA approval of MYFEMBREE represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S.”
“Uterine fibroids affect millions of women in the U.S. and account for over 250,000 hysterectomies each year, with heavy menstrual bleeding being one of the most bothersome symptoms,” said David Marek, CEO of Myovant Sciences, Inc. “The approval of MYFEMBREE represents the second FDA product approval for Myovant in less than one year. This is an important step forward as we seek to redefine care for women and men, not only through new medicines but through continued collaboration with the community.”
“MYFEMBREE’s approval is a testament to the shared commitment between Myovant and Pfizer to support women living with uterine fibroids,” said Nick Lagunowich, Global President, Internal Medicine at Pfizer. “We are excited to offer this new treatment option which will help provide much-needed symptom relief with the convenience of an oral, once-daily tablet.”
The primary objectives of the phase-lll LIBERTY trials were fulfilled with 72.1% & 71.2% of females are meeting the respondent criteria at week 24, as compared to 16.8% & 14.7% of females in the placebo group, respectively (both p < 0.0001). The response of the treatment was stated as the monthly blood loss with a volume of 80ml or less, and a 50% or higher decline in volume of menstrual blood loss by employing the alkaline hematin technique over the last 35 days of therapy compared to baseline.
MYFEMBREE reduced menstrual blood loss by 82% and 84.3% in women who took MYFEMBREE compared to placebo ( for both p < 0.0001). ADRs such as Hot flushes, alopecia, irregular uterine bleeding, and decreased libido was reported in approximately 3% of the women who were taking MYFEMBREE and at a higher rate than placebo. In both studies, no pregnancies were detected in MYFEMBREE groups.
Pfizer and Myovant are dedicated to assisting the women in the United States who have been prescribed with MYFEMBREE. Insurance coverage verification, copay assistance for privately insured patients, prior authorization support, and patient support for eligible uninsured patients are all available through MYFEMBREE Support Program.

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