SMC accepts Yselty®▼ (linzagolix) with Add-back Therapy for symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis

UK

UNDER EMBARGO UNTIL 00:01 13^th October 2025

FOR HEALTHCARE TRADE MEDIA

 

PRESS RELEASE

 

SMC accepts Yselty®▼ (linzagolix) with Add-back Therapy for symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis[1]

 

London, 13^th October 2025: Theramex is pleased to announce that the Scottish Medicines Consortium (SMC) has accepted the extended indication for linzagolix with Add-back Therapy (ABT) 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

 

Linzagolix is a once-daily pill that works by suppressing hormones that contribute to the symptoms of endometriosis.[2] This decision improves equity of access to approved medicines as a treatment option for endometriosis across the UK, with linzagolix having already been approved by the National Institute for Health and Care Excellence (NICE) for use on the NHS in England, Wales and Northern Ireland.[3]

 

Endometriosis is estimated to affect approximately 10% of women of reproductive age,[4] with around one in ten women (or those assigned female at birth) in the UK estimated to be living with the condition.[5] The SMC has accepted linzagolix as a treatment option for use within NHS Scotland for women who meet the eligibility criteria.¹

 

Endometriosis can cause chronic pelvic pain, dysmenorrhoea (painful menstruation) and impaired quality of life. ⁴ Symptom severity can range from mild to debilitating. Some women have no symptoms, others have episodic pelvic pain, and some experience constant pain in multiple body regions.[6] Symptoms of endometriosis can significantly impact the person’s quality of life, and their physical and psychosocial functioning, including social life, absenteeism from school or work, intimacy and intimate partnerships, as well as mental health and emotional well-being.[7]

 

The SMC decision is based on evidence from EDELWEISS 3, a randomised, double-blind and placebo-controlled study to evaluate the safety and efficacy of linzagolix for the management of eligible women with moderate-to-severe endometriosis-associated pain.² Six month management with linzagolix 200 mg with ABT demonstrated statistically significant reductions in both co-primary endpoints; a clinically meaningful reduction of dysmenorrhea and non-menstrual pelvic pain over the last 28 days of randomised management up to month three, with a stable or decreased use of analgesics compared to placebo.² The most common adverse reactions reported in the endometriosis population treated with the recommended dose of 200 mg with ABT included hot flushes and headache. Patients who completed the six month period had the option to enter the extension study (EDELWEISS 6) where they continued to receive linzagolix for six months.²

 

Dr Lucky Saraswat, Consultant Gynaecologist and Honorary Senior Lecturer, University of Aberdeen said: “As the need for more individualised approaches to endometriosis management becomes increasingly clear, the availability of an additional therapeutic option represents an important advance. It is encouraging to see women in Scotland gaining access to new treatment options, and I hope ongoing research will continue to broaden the choices available. Linzagolix is a valuable addition to the armamentarium of medical options for the management of endometriosis-associated pain, giving more choice to women.”

 

 

Sandy Lindsey, UK General Manager at Theramex said:

“There are too many women who are living with pain due to their endometriosis. With the SMC approval of linzagolix we can now offer an additional treatment option to women in Scotland, empowering clinicians and patients with more choices. This approval by the SMC is an important step on a much longer journey towards access to improved treatment for endometriosis across the UK.”

 

Emma Cox, Chief Executive at Endometriosis UK: “Endometriosis UK welcomes the addition of Linzagolix to the range of approved treatments for endometriosis in Scotland. It’s vital patients are able to make informed choices about what treatment options are right for them. Endometriosis UK is calling for further investment in research to find better management and treatment options for endometriosis, as well as research to find the cause and cure for the disease”

 

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

 

***ENDS***

 

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 on Theramex, visit https://www.theramex.com/uk/.

 

About Yselty^® (linzagolix)

Linzagolix is a selective, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signalling by binding competitively to GnRH receptors in the pituitary gland, thereby modulating the hypothalamic-pituitary-gonadal axis.²

Administration of linzagolix results in dose-dependent suppression of luteinizing hormone and follicle-stimulating hormone, leading to decreased blood concentrations of estradiol and progesterone. ²

In May 2025 the National Institute for Health and Care Excellence (NICE) recommended NHS reimbursement of the extended indication for Yselty^® (linzagolix) for the symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.3, Since June 2022, it has been approved in the UK by the MHRA for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, later receiving NICE approval for use on the NHS in England and Wales.² In March 2025, the indication was extended in the UK by the MHRA 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.²

 

The recommended dose of Yselty^® for symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis:

• 200mg once daily with concomitant hormonal add-back therapy (ABT).²

 

Please refer to the SmPC for full safety and clinical summary information.

 

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Theramex on medinfo.uk@theramex.com or Tel: 0333 0096795

 

 

Notes to Editors

 

Abbreviations

 

ABT: Add-back therapy

NHS: National Health Service

MHRA: Medicines & Healthcare products Regulatory Agency

SMC: Scottish Medicines Consortium

 

 

References

 

[1] SMC. (2025). Medicines advice – linzagolix (yselty). Available at: https://scottishmedicines.org.uk/medicines-advice/linzagolix-yselty-smc2631-full/

[2] Package Leaflet. Yselty 200mg film-coated tablets linzagolix.. Available at: https://products.mhra.gov.uk/search/?search=yselty&page=1&doc=Pil&rerouteType=0 [Accessed September 2025]

[3] NICE. (2025) Linzagolix for treating symptoms of endometriosis. Available at: https://www.nice.org.uk/guidance/ta1067/history [Accessed September 2025]

[4] World Health Organization. (2023) Fact sheet: Endometriosis [Internet]. Available at: https://www.who.int/news-room/fact-sheets/detail/endometriosis [Accessed September 2025]

[5] Endometriosis UK. Endometriosis Facts and Figures. Available at: https://www.endometriosis-uk.org/endometriosis-facts-and-figures [Accessed September 2025]

[6] Horne AW, Missmer SA. Pathophysiology, diagnosis, and management of endometriosis BMJ 2022;379:e070750;

[7] Culley L, Law C, Hudson N, Denny E, Mitchell H, Baumgarten M, et al. The social and psychological impact of endometriosis on women’s lives: a critical narrative review. Hum Reprod Update. 2013;19(6):625–39.