National Institute for Health and Clinical Excellence (NICE)
Printable version

Women with moderate to severe fibroids set to be offered new one-a-day treatment following final draft guidance from NICE

Around 4,500 women with uterine fibroids will be eligible for a new oral treatment after NICE recommended relugolix with estradiol and norethisterone acetate (also called Ryeqo and made by Gedeon Ritcher UK) in final draft guidance.

Treatment options for symptoms of uterine fibroids, include hormonal contraception and non-steroidal anti-inflammatory drugs (NSAIDs). But for treating moderate to severe symptoms, injectable gonadotrophin-releasing hormone (GnRH) agonists are often used before surgical options.

While the exact cause of fibroids is unknown, they have been linked to oestrogen. Taken once a day as a single tablet, comprising 40mg relugolix, 1mg estradiol and 0.5mg norethisterone acetate, this is another treatment option for women with moderate to severe symptoms, and works by reducing the release of hormones which control oestrogen and progesterone production by the ovaries.

Uterine fibroids are a non-cancerous growth that occur in or around the uterus in about 1 in 3 16-50 year olds, usually shrinking after the menopause. Symptoms can include prolonged heavy menstrual bleeding, pelvic pain and pressure, and fertility problems. There are currently limited long-term treatment options.

Relugolix with estradiol and norethisterone acetate offers an effective alternative to surgery and injectable GnRH agonists which also work to reduce the production of oestrogen and progesterone in the ovaries.

Helen Knight, interim director of medicines evaluation in the NICE Centre for Health Technology Evaluation, recently said:

“Uterine fibroids can have a profound effect on quality of life. Along with the many debilitating symptoms, there is a real lack of long-term options.

“This treatment has the potential to improve quality of life. As well as effectively reducing symptoms, it can be taken at home and is therefore more convenient than the injectable treatment, given in a hospital setting.

“It can also be used long term, which could mean improved and sustained symptom relief, it is well-tolerated, and it will mean thousands of women can avoid invasive surgery which always carries some risk.”

Minister for Women’s Health, Maria Caulfield, recently said:

“Around 1 in 3 women can suffer from uterine fibroids at some point in their life – the symptoms can have a profound impact on women’s health and lead to infertility if untreated.

“So this is another ground-breaking step forward to not only improve women’s quality of life and reduce symptoms, but to give them greater choice in the medication available and options for alternative, less invasive treatment.

“I am committed to closing the gender health gap so women can live healthier, happier lives – and later this year will publish the first ever Women’s Health Strategy to address these disparities.”

Relugolix with estradiol and norethisterone acetate for treating uterine fibroids will be available three months after the final guidance is published.

Final Apprasial Document – Relugolix with estradiol and norethisterone acetate


Channel website:

Original article link:

Share this article

Latest News from
National Institute for Health and Clinical Excellence (NICE)

Insight Paper: RegTech - Learnings from Regulators