Approvals

Theramex, a dedicated women’s health company, has announced that the Scottish Medicines Consortium (SMC) has recommended YSELTY (linzagolix) for the treatment of moderate or severe symptoms of uterine fibroids (UFs) in adult women of reproductive age.

The decision from the SMC will see YSELTY available on the NHS across Scotland.

Dr Sigi Joseph, co-founder of The Doctor Explains, GP and national lead for Women’s Health Plan said, "The SMC's approval of YSELTY is a significant milestone for women's health in Scotland. As both a GP and advocate for women's healthcare, I am delighted to see more treatment options becoming available for women and their health needs.”

While the medicine is still subject to additional monitoring, the SMC based its decision on the results from two identical studies, termed PRIMROSE, which investigated YSELTY’s efficacy and safety in women who had UFs coupled with heavy menstrual bleeding. UFs are the most prevalent tumours in the uterus, with heavy and prolonged bleeding, back or abdominal pain, dysmenorrhea, fullness, sexual dysfunction and constipation. Such symptoms can cause major disruptions to daily life, along with additional costs of medications. YSELTY contains linzagolix chlorine, which binds to GnRH receptors in the pituitary gland and leads to decreased hormone levels of oestrogen and progesterone in the blood. Both hormones are linked to the growth of UFs.

"Women should not have to endure painful gynaecological conditions – and UFs are just one of many issues in women's health that needs immediate improvement,” states Tina Back house, UK general manager at Theramex. “We are committed to working closely with SMC and NHS Scotland to ensure that eligible women in Scotland will now have access to YSELTY – diversifying their treatment options”

UFs occur in up to 70% of women who are of reproductive age. Black women are two-to-three times more likely to develop UFs compared to White women.