Theramex Announces European Commission Approval for Yselty^®▼ (linzagolix) for Symptomatic Treatment of Endometriosis in Women with a History of Previous Medical or Surgical Treatment for their Endometriosis

For Media and Investors only.

Ireland, December 20^th, 2024 – Theramex, a global pharmaceutical company dedicated to women’s health, is pleased to announce that the European Commission (EC) has approved an extended indication for Yselty^® (linzagolix), an oral gonadotropin-releasing hormone (GnRH) antagonist, for the symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.¹ This approval, effective immediately, applies to EU markets (excluding the UK and non-EU markets).

Theramex in-licensed Linzagolix from Kissei Pharmaceutical Co., Ltd. in 2022, and this achievement underscores Theramex’s unwavering commitment to advancing women’s health.

Endometriosis is a chronic and often painful condition that affects millions of women globally, and can significantly impact their quality of life.²

“We are delighted that the European Commission has approved the extended indication for Yselty^® (linzagolix), providing women with endometriosis an additional treatment option to manage their symptoms,” said Robert Stewart, Theramex CEO. “This marks another important step in our commitment to improving women’s health by offering more choices for treatment. At Theramex, we remain dedicated to empowering women to take control of their health and enhance their quality of life.”

The EC approval follows the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) positive opinion in October 2024,³ based on results from the EDELWEISS 3 study.⁴ The approval for amending the marketing authorisation was granted by Decision C(2022) 4199(final).

About EDELWEISS 3⁴

The efficacy of linzagolix was evaluated in a Phase 3, randomised, double-blind, placebo-controlled study (EDELWEISS 3) involving 484 women aged 18–49 with moderate to severe endometriosis-associated pain, treated for up to six months.

The daily dose of 200 mg linzagolix with add-back therapy (ABT) met the primary efficacy objectives, demonstrating clinically meaningful and statistically significant reductions in dysmenorrhea and non-menstrual pelvic pain at three months, with stable or reduced use of analgesics. At three months, 73% of participants in the 200 mg linzagolix with ABT group responded to treatment for dysmenorrhea (P < 0.001 versus placebo) and 47% showed a response for non-menstrual pelvic pain (P = 0.007 versus placebo) – compared with rates of 24% and 31% of participants in the placebo group respectively.

The most frequent adverse event reported was headache, occurring at similar rates in both the linzagolix 200 mg with ABT and placebo groups (10.5% versus 8.0%, respectively). Hot flashes and fatigue were reported more frequently in the linzagolix 200 mg with ABT group compared to the placebo group (6.8% each for linzagolix versus 2.5% each for placebo).

About Yselty^® (linzagolix)¹

Linzagolix is a once daily, oral GnRH receptor antagonist. Since June 2022, it has been approved in the EU for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.In December 2024, the indication was extended in the EU to include the symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.

About Theramex

Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women of all ages by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause, and osteoporosis. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them, and is committed to listening to and understanding its patients, serving their needs, and offering effective healthcare solutions that care for and support women through different stages of their lives.

For further information about Theramex, please contact:
info@theramex.com

About Kissei:

Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.”

As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases. Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co., Ltd.

References

1. European Medicines Agency. YSELTY EU SmPC. Available at: https://ec.europa.eu/health/documents/community-register/2024/20241122164448/anx_164448_en.pdf. Last accessed: December 2024.
2. University of Oxford. Global study shows the experience of Endometriosis is rooted in genetics. Available at: https://www.ox.ac.uk/news/2023-03-14-global-study-shows-experience-endometriosis-rooted-genetics#:~:text=Endometriosis%20has%20enormous%20implications%20on,depression%2C%20anxiety%2C%20and%20infertility. Last accessed December 2024.
3. European Medicines Agency. Yselty – opinion on variation to marketing authorisation. Available at: https://www.ema.europa.eu/en/medicines/human/variation/yselty. Last accessed December 2024.
4. Donnez et al, 2024. Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3). Human Reproduction. 3;39(6):1208-1221. doi: 10.1093/humrep/deae076.