NICE recommends new option for treating symptoms of uterine fibroids

As many as 30,000 adults could benefit from linzagolix, a new treatment option for moderate to severe symptoms of uterine fibroids, after it was recommended in guidance from NICE published today.

Taken once a day as a single tablet, linzagolix (also called Yselty and made by Theramex) is a gonadotropin-releasing hormone (GnRH) antagonist that clinical trials show is effective in reducing the bleeding caused by uterine fibroids, and also shrinking the fibroids themselves, compared with placebo. It works by reducing the release of hormones which control oestrogen and progesterone production by the ovaries.

Linzagolix is recommended for use as a longer-term treatment (more than 6 months) and is not for people who need short-term treatment, such as before planned uterine fibroid surgery. It can also be taken with or without hormonal add-back therapy (ABT). ABT involves taking a low dose of hormones at the same time as a GnRH antagonist to give the body enough hormones to protect bones and control any possible side effects.

Uterine fibroids are non-cancerous growths that develop in or around the uterus (womb). They occur at reproductive age and can become smaller after menopause. Their exact cause is not known, but they have been linked to oestrogen and progesterone. Around 66% of women develop at least 1 uterine fibroid during their lifetime and 33% of women will develop symptoms from uterine fibroids.

Most fibroids are small and do not cause symptoms. However, some people with fibroids develop symptoms that can include very heavy or long menstrual periods or pelvic pressure or pain. People with moderate to severe symptoms of uterine fibroids can experience a substantial negative effect on their quality of life.

Usual treatment for moderate to severe symptoms of uterine fibroids includes hormonal treatments, such as GnRH receptor agonists and antagonists, and supportive care.

Linzagolix is an additional option for adults with fibroids and allows clinicians to provide more individualised care in the treatment of moderate to severe symptoms. It also offers an effective alternative to injectable GnRH agonists.

Jonathan Benger, NICE chief medical officer and deputy chief executive said: “I am pleased we have been able to recommend a further treatment option for managing moderate to severe symptoms of uterine fibroids.

“Uterine fibroids can have many debilitating symptoms including pain and heavy menstrual bleeding. If left untreated they can lead to infertility and have a substantial effect on quality of life.

“Linzagolix offers greater flexibility as it can be taken either with or without hormone therapy and means clinicians can provide more personalised care in the treatment of this often debilitating condition.”