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NICE recommends first oral treatment for women with uterine fibroids

Gedeon Richter UK announced that the National Institute for Health and Care Excellence (NICE) has published final guidance recommending Ryeqo(relugolix 40 mg, estradiol 1 mg, and norethisterone acetate 0.5 mg – herein “relugolix combination therapy”), for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.1

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.1

Around one in three women might suffer from uterine fibroids (usually between the ages of 16-50 years),2 equating to more than 4 million in the UK.3 Symptoms severe enough to require treatment are estimated in around 25% of women of reproductive age,4 of which the relugolix combination therapy will be available to those women with moderate to severe symptoms of uterine fibroids.1 The new relugolix combination therapy should be available on the NHS in England within three months from now, and within two months in Wales. 

David Jordan, Medical Director UK and Ireland, Gedeon Richter said: “The symptoms of uterine fibroids – such as heavy menstrual bleeding and pain – can have a significant impact on a patient’s quality of life.” 

“While the symptoms are often debilitating, there are limited therapies currently available to treat them. 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.” 

Tamas Neubauer, Managing Director UK and Ireland, Gedeon Richter said: “We are pleased that NICE has recognised the value of the relugolix combination therapy as a long-term treatment, which could help women with uterine fibroids achieve improved symptom relief.” 

“Aligned to the Women’s Health Strategy published earlier this year, our hope is that this new option will provide greater choice, helping to close the gender health gap so women can live happier and healthier lives in the future.”

References 

1 Ryeqo. Summary of Product Characteristics. 29 July 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/ryeqo-epar-product-information_en.pdf Last accessed: October 2022 

2 NHS. Overview: Fibroids. Available at: https://www.nhs.uk/conditions/fibroids/ Last accessed: October 2022 

3 Office for National Statistics. 25 June 2021. Estimates of the population for the UK, England and Wales, Scotland and Northern Ireland: UK female population; ages 16-50 years. Mid-2020 edition. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland Last accessed: October 2022 

4 Stewart EA et al. Epidemiology of uterine fibroids: a systematic review. BJOG 2017;124:1501–1512. 

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