Gedeon Richter Plc. ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland GmbH ('SMPS') announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has adopted a positive opinion recommending the approval of a Type II Variation application for RYEQO(R) (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis. The European Commission ("EC") will review the CHMP recommendation and a final decision on the Marketing Authorization Application is expected to be available in the coming months. The decision will be applicable to all member states of the European Economic Area. RYEQO(R) was initially approved by the EMA in July 2021 for the treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. This application is supported by two, 24-week, multi-national clinical studies (SPIRIT 1 and SPIRIT 2) in more than 1,200 women with moderate-to-severe pain associated with endometriosis, as well as the 80-week, open-label extension study to assess longer-term use of RYEQO(R) . Together, these data represent up to two years of efficacy and safety information with RYEQO(R). Approximately 10% of women of reproductive age have endometriosis. Many women with endometriosis-associated pain are not able to manage their pain symptoms with current treatment options, underscoring the high unmet need for this disease . Endometriosis is a disease in which tissue similar to the uterine lining is found outside the uterine cavity, commonly in the lower abdomen or pelvis, on ovaries, the bladder, and the colon. This endometrial-like tissue outside the uterus results in chronic inflammation and can cause scarring and adhesions. The symptoms associated with endometriosis include painful periods and chronic pelvic pain, painful ovulation, pain during or after sexual intercourse, heavy bleeding, fatigue, and infertility. Endometriosis can also impact general physical, mental, and social well-being. RYEQO(R) (relugolix 40 mg, estradiol 1.0 mg, and
norethisterone acetate 0.5 mg) is approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO(R) contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethisterone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.