The National Institute for Health and Care Excellence (NICE) has published final guidance recommending Ryeqo (relugolix 40mg, estradiol 1mg, and norethisterone acetate 0.5mg), for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The decision makes the relugolix combination therapy the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist funded for these women on the NHS in England and Wales.
Around one in three women might suffer from uterine fibroids (usually between the ages of 16-50 years), equating to more than four million in the UK.
The new relugolix combination therapy should be available on the NHS in England within three months from now, and within two months in Wales.
“The symptoms of uterine fibroids – such as heavy menstrual bleeding and pain – can have a significant impact on a patient’s quality of life,” said David Jordan, Medical Director UK and Ireland, Gedeon Richter. “NICE’s recommendation represents an important milestone, providing a once-daily oral alternative to injectable treatment or surgery, that may be effective at reducing the symptoms associated with moderate to severe symptoms of uterine fibroids, and can be taken from the convenience of home.”
The NICE recommendation is based on outcomes from the Phase III LIBERTY programme, in which 71-73% of women receiving the relugolix combination therapy responded to treatment, compared with 15-19% in the placebo groups.
In August 2022, the Government published the first ever Women’s Health Strategy for England. The plan aims to boost health outcomes for women and girls, reducing the time they spend in ill health and disability compared to men.
