Myovant Sciences and Pfizer have 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) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.
The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet, and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.
“Endometriosis is a painful, chronic disease with limited therapies to manage symptoms,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis.”
“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We look forward to making MYFEMBREE available to women with endometriosis and broadening their options in managing this complex disorder.”
Endometriosis is a condition in which tissue similar to the uterine lining is found outside of the uterine cavity, which often causes disruptive symptoms like painful periods, fatigue, pain in the lower back and abdomen, heavy menstrual bleeding, and even painful or difficult sexual intercourse. For endometriosis-associated pain, current treatment options include prescription and over-the-counter pain medications, combined oral contraceptives, progestins, danazol, GnRH agonists and antagonists, and surgical interventions.