NICE recommends first oral GnRH antagonist for the treatment of moderate to severe symptoms of uterine fibroids

London, United Kingdom, 24 October 2022 – Gedeon Richter UK Ltd. (“Gedeon Richter”) today 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. 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 4 million in the UK. Symptoms severe enough to require treatment are estimated in around 25% of women of reproductive age, of which the relugolix combination therapy will be available to those women with moderate to severe symptoms of uterine fibroids. 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. “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.”

The NICE recommendation is based on outcomes from the Phase 3 LIBERTY programme, which consists of two replicate, 24-week, double-blind, randomised, multinational clinical trials (LIBERTY 1 [n=388] and LIBERTY 2 [n=382]). Pivotal data, published in the New England Journal of Medicine, which showed that 73% [n=94/128] of women receiving the relugolix combination therapy in LIBERTY 1 and 71% [n=89/125] in LIBERTY 2 responded* to treatment (primary endpoint), compared with 19% [n=24/127] and 15% [n=19/129] of women, respectively, in the placebo groups (p<0.001 for both comparisons).

The overall incidence of adverse events in the relugolix combination therapy group was 62% [n=79/128] in LIBERTY 1 and 60% [n=76/126] in LIBERTY 2, compared with 66% [n=84/127] and 59% [n=76/129] respectively in the placebo group.⁵ Hot flush was the most frequently reported adverse event in both trials, occurring in 11% [n=14/128] of the relugolix combination therapy group in LIBERTY 1 and 6% [n=7/126] in LIBERTY 2, compared with 8% [n=10/127] and 4% [n=5/129] respectively in the placebo group.

“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,” said Tamas Neubauer, Managing Director UK and Ireland, Gedeon Richter. “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.”

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 when compared to men.

*Volume of menstrual blood loss of less than 80 ml and a reduction of at least 50% from the baseline volume of menstrual blood loss, as measured by the alkaline hematin method over the last 35 days of the treatment period.