Women in England to be offered a daily tablet for fibroids, Nice says

Thousands of women in England who suffer symptoms caused by fibroids are to be offered a daily tablet on the NHS that shrinks them and reduces symptoms.

In guidance published on Wednesday, the National Institute for Health and Care Excellence (Nice) gave the green light to a treatment option for patients with moderate to severe symptoms caused by uterine fibroids

Linzagolix – also called Yselty and made by Theramex – works by reducing the release of hormones which control oestrogen and progesterone production by the ovaries.

The guidance is expected to give more choice to at least 30,000 patients in England, Nice said.

Jonathan Benger, the chief medical officer and deputy chief executive of Nice, 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.”

Uterine fibroids are noncancerous growths that develop in or around the womb. Their exact cause is not known, but they have been linked to oestrogen and progesterone.

Fibroids usually develop in women under the age of 50 when oestrogen levels are at their highest. After menopause, they will often shrink without treatment.

About two thirds of women develop at least one uterine fibroid during their lifetime. Most are small and do not cause symptoms. Many women are unaware of them because they do not have any symptoms.

However, one in three women (33%) will experience symptoms from uterine fibroids, Nice said.

They can include very heavy or long menstrual periods, or pelvic pressure or pain. Women with moderate to severe symptoms of uterine fibroids can experience a substantial negative effect on their quality of life.

Symptoms also include abdominal pain, lower back pain, a frequent need to urinate, constipation and pain or discomfort during sex. In rare cases, complications can affect pregnancy or cause infertility.

Usual treatment for moderate to severe symptoms of uterine fibroids includes hormonal medications, such as gonadotropin-releasing hormone (GnRH) receptor agonists and antagonists, and supportive care.

Linzagolix will enable doctors to provide more individualised care, Nice said. It also offers an alternative to injectable GnRH agonists.

Taken once a day as a single tablet, linzagolix is a 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.

Nice said in the guidance that it is recommending its use as a longer-term treatment for more than six months. It is not for women who need short-term treatment, such as before planned uterine fibroid surgery, officials added.

The tablet 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.