MHRA licenses uterine fibroid treatment for women in Great Britain

pharmafile | October 26, 2021 | News story | Manufacturing and Production  

The MHRA has granted a licence for Ryeqo (a relugolix combination therapy), for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. This relugolix combination therapy is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist licensed in Great Britain for these women.

Gedeon Richter, manufacturers of Ryeqo, has initiated discussions with NICE and the SMC, and final advice for the availability of the relugolix combination therapy is expected to be published in 2022.

Uterine fibroids are noncancerous tumours that develop in or around the uterus. They are the most common benign pelvic tumour in women, and approximately one in three women may develop uterine fibroids (usually between the ages of 16 and 50), equating to more than 4 million in the UK.

25% of women of reproductive age suffer from symptoms which are severe enough to require treatment. These symptoms include heavy menstrual bleeding, uterine fibroids associated pain, and anaemia, meaning that uterine fibroids severely impact the quality of life of people suffering from them.

The relugolix combination therapy contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen), 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 luteinising hormone (LH) and follicle-stimulating hormone (FSH) from the anterior pituitary gland.

“The granting of a licence for relugolix combination therapy is fantastic news and we are delighted that the value of this non-invasive treatment has been recognised,” said Tamas Neubauer, Managing Director UK and Ireland, Gedeon Richter.

“We want to redefine care for women living with uterine fibroids and we are engaging with the relevant health authorities throughout Great Britain with a view to securing NHS reimbursement as soon as possible. Our hope is that women suffering from symptoms with this common condition may benefit from greater treatment choice in the future.”

Lina Adams

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