BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The approval is supported by efficacy and safety data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies, which were published in the New England Journal of Medicine. Under the terms of their previously announced collaboration, Myovant and Pfizer will jointly commercialize MYFEMBREE in the U.S. MYFEMBREE is expected to be available 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, Chief Executive Officer 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 for 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 Phase 3 LIBERTY studies each met the primary endpoint, with 72.1% and 71.2% of women in the MYFEMBREE groups achieving the responder criteria compared with 16.8% and 14.7% women in the placebo groups at Week 24, respectively (both p
