NICE recommends Yselty®▼ (linzagolix) for treating moderate to severe symptoms of uterine fibroids in adult women of reproductive age

London, 14^th August 2024: Theramex has announced that the National Institute for Health and Care Excellence (NICE) has recommended Yselty® for the treatment of moderate to severe symptoms of uterine fibroids (UFs), aligned to the product indication in adult women of reproductive age.^{1, 2}

UFs occur in approximately 70% of women of reproductive age, with black women two to three times more likely to develop UFs compared to white women.³ Approximately 25% of women will experience symptoms severe enough to require treatment.³ 

Symptoms caused by UFs can include pelvic pressure, back or abdominal pain, fullness, sexual dysfunction, dysmenorrhea and bladder or bowel symptoms.⁴ The symptoms of UFs can also have a negative impact on emotional wellbeing, with many women feeling embarrassed, worried, anxious, sad or depressed.⁵ Longer, heavier, and surprise bleeding compared to ‘normal’ menstrual bleeding can also result in excessive costs to women for feminine products, replacing or cleaning soiled clothing and medications. These costs, in addition to the symptoms of UFs, can have a major impact on a woman’s quality of life. ⁵

This decision by NICE means that Yselty® will be available for eligible women across England and Wales through the NHS.

The NICE decision is based on evidence from the two PRIMROSE studies (of replicate design) investigating the efficacy and safety of Yselty® in women who have uterine fibroids with heavy menstrual bleeding (HMB). ^1,2

Dr Aziza Sesay Vice Chair and Creative Director of Black Female Doctors UK and GP, said, “It’s brilliant to hear that there will be more options for the treatment of fibroids on the NHS in England and Wales for women battling symptoms like heavy bleeding and pelvic pain. We certainly need to ensure we keep advocating for accessible treatment for all women who are in need, especially the communities with higher prevalence of uterine fibroids such as Black women like myself.”³

Dame Lesley Regan, Professor of Obstetrics and Gynaecology at Imperial College London said, “No woman should have to suffer as a result of their menstrual health, and this latest decision by NICE is a necessary step in ensuring that women have greater access to treatment and care. If we want to close the gender health gap, we need to ensure that we are providing women access to a diverse range of treatments that work for them and their needs.”

Tina Backhouse, UK General Manager at Theramex said, “We are delighted that eligible women in England and Wales will now be able to access Yselty® through the NHS. We are continuing to work with NICE and the NHS in the hope that we can provide as many women as possible the opportunity to access this treatment, wherever they live.”

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

About Theramex

We are Theramex, a dedicated women’s health company committed to supporting the health needs of all women at every stage of their life. Our products have helped more than 6 million women live better lives.

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

About Yselty^® (linzagolix)

Yselty^® is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist available in either 100mg or 200mg doses for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.  It contains the active substance linzagolix choline.¹,² By attaching to GnRH receptors (targets) in the pituitary gland in the brain it blocks the action of naturally occurring GnRH.^1,2 Blocking GnRH leads to decreased blood concentrations of estrogen and progesterone, two hormones that at high levels are linked to the growth of UFs.⁶

The recommended dose of Yselty^®  is:

• 100 mg or 200 mg once daily with concomitant hormonal ABT

• 100 mg once daily for women in whom ABT is not recommended or who prefer

to avoid hormonal therapy (see section 5.1)

• 200 mg once daily for short-term use (< 6 months) in clinical situations when

reduction of uterine and fibroid volume is desired. ^1,2