Theramex's uterine fibroid drug Yselty backed for NHS use
A daily oral therapy for uterine fibroids has been recommended for NHS by NICE, providing a new option for around 30,000 women in England and Wales.
Theramex's GnRH antagonist Yselty (linzagolix) has been given the green light for use in women with moderate to severe symptoms caused by uterine fibroids – benign tumours that develop in the womb, causing debilitating symptoms including heavy bleeding, pain, and abdominal bloating, and which if left untreated can cause infertility.
Around two-thirds of women will develop at least one uterine fibroid in their lifetime, while one-third will be symptomatic. Black women are roughly two-to-three times more likely to develop UFs compared to white women.
It's the second positive opinion from NICE on a Theramex women's health product, coming just a few days after the health technology assessment (HTA) agency backed the company's Eladynos (abaloparatide) for postmenopausal women at increased risk of bone fractures due to osteoporosis.
Yselty is the only drug in the GnRH antagonist class with a dosing regimen that can be used for women of reproductive age with uterine fibroids who cannot or do not want to take hormonal add-back therapy (ABT), used to provide enough hormone in the body to prevent bone loss and other side effects.
It is an alternative to Gedeon Richter's Ryeqo (relugolix/estradiol/norethisterone acetate), which includes ABT in the formulation and was cleared for NHS use in 2022, but Theramex's drug can also be given in tandem with ABT if that is appropriate. NICE notes there have been no direct comparisons between Yselty and Ryeqo in clinical trials.
It has been recommended for use as a longer-term treatment of six months or more and is not intended for people who need short-term treatment, for example, before planned uterine fibroid surgery, according to NICE's technology appraisal guidance.
"I am pleased we have been able to recommend a further treatment option for managing moderate to severe symptoms of uterine fibroids," commented Jonathan Benger, NICE's chief medical officer and deputy chief executive.
"Linzagolix offers greater flexibility, as it can be taken either with or without hormone therapy and means clinicians can provide more personalised care in the treatment of this often debilitating condition."
During the appraisal process for Yselty, a clinical expert told NICE's appraisal committee that uterine fibroids can lead to "the breakdown of relationships and missed career opportunities, which can further affect mental health and quality of life."
