Hungarian phrama company Gedeon Richter Plc. has announced that it has submitted a Type II Variation application for RYEQO® to the European Medicines Agency (EMA) for the treatment of moderate to severe pain associated with endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis. RYEQO® is already approved by the EMA for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age since July 2021.
“Expanding the therapeutic reach of our core innovative products takes us further on the way of consolidating our leading role in addressing women’s health issues,” Gábor Orbán, CEO of Gedeon Richter said. “If approved, this new therapy will offer a treatment of choice to many women suffering from endometriosis,” he added.
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®. Together, these data represent up to two years of efficacy and safety information with RYEQO®.
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.
Initial treatment options for pain associated with endometriosis include oral contraceptives and progestins as well as non-prescription and prescription pain medications for acute pain. In more severe cases, GnRH agonists such as leuprorelin (leuprolide acetate) are used for short-term treatment.
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