The US Food and Drug Administration (FDA) has approved the use of an oral pill (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe pain caused by endometriosis in premenopausal women. The medicinal product is taken once a day, and the duration of treatment is up to 24 months. The development of the preparation is the work of the American biotechnology company Pfizer and the British Myovant Sciences. The approval is supported by one year of efficacy and safety data. The medicinal product is also approved for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. “Endometriosis is a painful chronic disease with limited therapeutic approaches to address the symptoms,” explains the British company’s chief medical officer, Dr. Juan CA Ferreira. According to him, this is a good opportunity, both for women suffering from the disease, and for the medical community that offers treatment for its patients. “This approval is an important milestone reflecting our commitment to women’s health in areas with significant underserved therapies,” said Dr. James Rusnak, senior vice president and chief director of internal global product development at the US pharmaceutical company. “We look forward to making the drug available to women with endometriosis and expanding their options for managing this complex disorder,” he added. Endometriosis is a serious chronic disease that requires long-term interventions. Optimization of medical therapies is the recommended treatment paradigm. The preparation is an option for up to two years of pharmacological treatment of moderate to severe pain associated with endometriosis in premenopausal women. Endometriosis can affect general physical, mental and social well-being, requiring a multidisciplinary approach to patient care. An estimated 190 million women suffer from symptoms of endometriosis worldwide. There are approximately 7.5 million premenopausal women in the US with endometriosis, and approximately 75-80% of these are symptomatic. Many women with pain due to endometriosis are unable to manage their pain symptoms with current treatment options. It can take between four and eleven years to be diagnosed. References: Myovant Sciences and Pfizer Receive US FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis. (Basel, Switzerland & New York, USA, August 5th, 2022). Pfizer – https://www.pfizer.com/news/press-release/press-release-detail/myovant-sciences-and-pfizer-receive-us-fda-approval