London, United Kingdom, Tuesday 26 October 2021
Gedeon Richter UK Ltd. (“Gedeon Richter”) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for 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 licensed in Great Britain for these women. 1
The MHRA licence 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, which have been published in the New England Journal of Medicine, 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).2
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.2Hot 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.2
Gedeon Richter has initiated discussions with the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), with final advice for the availability of the relugolix combination therapy expected to be published in 2022.
Ryeqo sold as brand name Myfembree in USA.
The relugolix combination therapy contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen), which may reduce the risk of bone loss, and norethisterone acetate (a progestin), which is necessary when women with a uterus (womb) take estrogen.
Relugolix is a non-peptide GnRH receptor antagonist that binds to and inhibits GnRH receptors in the anterior pituitary gland, resulting in a dose dependent decrease in the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the anterior pituitary gland.The reduction in FSH concentrations prevents follicular growth and development, thereby reducing the production of estrogen. Prevention of an LH surge inhibits ovulation and development of the corpus luteum, which precludes the production of progesterone.