Myovant Sciences and Pfizer Inc. on Monday announced that the US Food and Drug Administration (FDA) has approved Myfembree 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.
According to the companies, Myfembree also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialise Myfembree in the United States and the product is available immediately.
“Endometriosis is a painful, chronic disease with limited therapies to manage symptoms. 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,” said Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant Sciences, Inc. in a statement.
“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need. We look forward to making Myfembree available to women with endometriosis and broadening their options in managing this complex disorder,” James Rusnak, M.D., Ph.D., senior vice president, chief development officer, internal medicine and hospital, global product development at Pfizer stated on Monday.
Myfembree offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. Endometriosis is a serious chronic condition that requires long-term interventions. Optimization of medical therapies is the recommended treatment paradigm. Myfembree introduces an option for up to two years of pharmacological management of moderate to severe pain associated with endometriosis in pre-menopausal women, the company claims.
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. At present, 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.
Endometriosis can also impact general physical, mental, and social well-being, requiring a multi-disciplinary approach to care. Approximately 190 million women suffer from symptoms of endometriosis globally.