Women in England are being offered a daily tablet to treat fibroids, says Nice
Thousands of women in England suffering from symptoms caused by fibroids are being prescribed a daily pill through the NHS that shrinks the fibroids and reduces symptoms.
In guidance published on Wednesday, the National Institute for Health and Care Excellence (Nice) has given 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 that regulate the ovaries’ production of estrogen and progesterone.
The guideline is expected to provide more choice to at least 30,000 patients in England, Nice said.
Jonathan Benger, Chief Medical Officer and Deputy Chief Executive of Nice, said: “I am pleased that we have been able to recommend a further treatment option for managing moderate to severe symptoms of uterine fibroids.
“Uterine fibroids can cause many debilitating symptoms, including pain and heavy menstrual bleeding. If left untreated, they can lead to infertility and have a significant impact on quality of life.
“Linzagolix offers greater flexibility as it can be taken with or without hormone therapy, meaning clinicians can provide more personalised care when treating this often debilitating condition.”
Uterine fibroids are noncancerous growths that develop in or around the uterus. Their exact cause is unknown, but they have been linked to estrogen and progesterone.
Fibroids usually develop in women under 50, when estrogen levels are highest. They often shrink without treatment after menopause.
About two-thirds of women will develop at least one uterine fibroid in their lifetime. Most are small and cause no symptoms. Many women are unaware of them because they have no symptoms.
However, one in three women (33%) experiences symptoms of uterine fibroids, Nice said.
They may include very heavy or long periods, or pelvic pressure or pain. Women with moderate to severe symptoms of uterine fibroids may experience a substantial negative impact on their quality of life.
Symptoms include abdominal pain, lower back pain, frequent urination, constipation, and pain or discomfort during sex. In rare cases, complications can affect pregnancy or cause infertility.
The usual treatment for moderate to severe symptoms of uterine fibroids consists of hormonal medications, such as gonadotropin-releasing hormone (GnRH) receptor agonists and antagonists, and supportive care.
Linzagolix allows doctors to provide more individualized care, Nice said. It also offers an alternative to injectable GnRH agonists.
Linzagolix is a GnRH antagonist taken as one tablet once a day. In clinical studies, it has been shown to be effective in reducing bleeding caused by uterine fibroids. It also shrinks the fibroids themselves, compared with placebo.
Nice said in the guidance that it recommends its use as a longer-term treatment, longer than six months. It is not for women who need short-term treatment, such as for planned surgery for uterine fibroids, 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 possible side effects.