December 23, 2024
Regarding the approval of the additional indication for endometriosis in Europe for the GnRH antagonist YSELTY® (generic name linzagolix)
Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") announced today that Theramex (UK), to which Kissei licensed out its technology for the GnRH antagonist "YSELTY®" (generic name linzagolix, development number in Japan: KLH-2109), has received an additional indication for endometriosis from the European Commission.
"YSELTY®" is launched in five European countries by Theramex for the indication of uterine fibroids. Additionally, Theramex submitted an application to the European Medicines Agency (EMA) for an additional indication for endometriosis. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in its October meeting, leading to the approval of the additional indication.
The agent is being developed for the treatment of uterine fibroids and endometriosis in Japan, and it is being developed by out-licensed companies such as Theramex Inc, overseas. We are committed to making efforts to ensure that this drug will contribute widely to improve the QOL of patients around the world.
It has negligible effects on Kissei's consolidated business forecasts for the fiscal year ending in March 2025. The consolidated business forecast for fiscal year ending March 2025 including this matter will be disclosed at the Financial Results for third quarter of fiscal year ending March 2025 to be held on February 3, 2025.
《 Reference 》
About linzagolix (development number in Japan: KLH-2109)
Linzagolix is a novel orally available GnRH (gonadotropin-releasing hormone) antagonist discovered and developed by Kissei, which antagonizes GnRH at the GnRH receptor in the pituitary gland and reduces estrogen production in the ovaries by suppressing the secretion of the gonadotropin, a gonadotrophic hormone.
Linzagolix was launched in Germany this September under the product name "YSELTY®" by Theramex. Subsequently, it has also been launched in Spain, Poland, Italy, and the United Kingdom, with plans to gradually launch in other EU countries. Additionally, an approval application has been submitted in Australia. In Taiwan, Synmosa BioPharma (Taiwan) has filed for approval, and in South Korea, JW Pharma (South Korea) is preparing to start development.
In Japan, Kissei is preparing to submit an application for approval targeting uterine fibroids, and has completed Phase II clinical trials for endometriosis.
About Theramex
Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause, and osteoporosis. Theramex's commitment is to listen to and understand its patients, serve their needs, and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.
For further information on Theramex, please visit their website (https://www.theramex.com/).
About Endometriosis
Endometriosis is a condition in which the endometrium, the tissue that normally lines the inside of the uterus, or tissue that closely resembles it, occurs and continues to grow in locations outside the uterine cavity, such as the ovaries, peritoneum, or within the uterine wall. It is commonly found in women in their 20s to 30s, causing severe abdominal pain and is also one of the causes of infertility.