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Theramex Launches Linzagolix (Yselty) for Uterine Fibroids in Europe

• Theramex has launched Yselty (linzagolix), a GnRH receptor antagonist developed by Kissei, in Germany for treating moderate to severe uterine fibroids. • Yselty is approved in Europe and the UK for adult women of reproductive age, offering a new option for those who cannot take hormonal agents. • Clinical trials confirmed Yselty's efficacy both with and without add-back therapy, improving bleeding and pain symptoms associated with uterine fibroids. • Kissei has out-licensed linzagolix development to multiple companies, with ongoing Phase III trials in Japan for uterine fibroids and Phase II trials for endometriosis.

Theramex has announced the first commercial sale of Yselty (linzagolix) in Germany, a treatment for uterine fibroids developed by Kissei Pharmaceutical. Linzagolix, a GnRH receptor antagonist, offers a novel approach to managing moderate to severe uterine fibroids in adult women of reproductive age. The drug's approval and launch mark a significant advancement in women's health, providing an alternative for patients who cannot use hormonal agents.

Mechanism of Action and Clinical Efficacy

Linzagolix functions by antagonizing GnRH receptors in the pituitary gland, which in turn suppresses the secretion of gonadotropin and reduces estrogen production in the ovaries. This mechanism helps to alleviate the bleeding and pain symptoms associated with uterine fibroids. Phase III clinical trials conducted in the U.S. and Europe demonstrated the drug's efficacy, both in combination with add-back therapy and as a standalone treatment. These trials led to marketing approval from the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in June 2022.

Addressing Unmet Needs in Uterine Fibroid Treatment

Uterine fibroids are benign tumors that develop in the uterine myometrium and grow in a sex hormone-dependent manner. Common symptoms include excessive menstruation, anemia, dysmenorrhea, pressure symptoms, pain, and infertility. Hypermenorrhea and chronic pain significantly impact patients' quality of life (QOL). Yselty offers a tailored treatment option, particularly beneficial for patients who cannot tolerate hormonal agents, thus filling a critical gap in current treatment strategies.

Global Development and Availability

Kissei Pharmaceutical has licensed the development and marketing rights for linzagolix to several companies worldwide. Bio Genuine (China) holds exclusive rights for China, Synmosa BioPharma (Taiwan) has filed for approval in Taiwan, and JW Pharma (South Korea) is preparing to initiate development in South Korea. In Japan, Kissei is conducting Phase III clinical trials for uterine fibroids and has completed Phase II clinical trials for endometriosis, underscoring a commitment to expanding the drug's availability and indications.

Theramex's Commitment to Women's Health

Theramex, a global specialty pharmaceutical company dedicated to women's health, is committed to providing innovative and established brands that support women through various stages of life. Their portfolio includes treatments for contraception, fertility, menopause, and osteoporosis. Theramex aims to be a lifetime partner for women and healthcare professionals by offering patient-focused solutions that improve women's lives.
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Reference News

[1]
Launch of YSELTY® (generic name linzagolix) for uterine fibroid treatment in Europe
kissei.co.jp · Sep 17, 2024

Kissei announced Theramex's first commercial sale of YSELTY®, a GnRH receptor antagonist for uterine fibroids, in German...

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