As many as 30,000 women could benefit from a new treatment to manage uterine fibroids, the National Institute for Health and Care Excellence (NICE) has estimated.
Linzagolix, a GnRH antagonist, has been recommended as a longer term treatment – more than six months – for people with moderate to severe symptoms.
It follows two clinical trials which showed it is effective at reducing bleeding caused by uterine fibroids compared with placebo.
The once-a-day pill has also been shown to shrink the fibroids and can be taken with or without hormonal add-back therapy, NICE said.
It will provide clinicians and patients with alternative options to manage what can be debilitating symptoms, the expert committee reviewing the evidence said.
Around 66% of women develop at least one uterine fibroid during their lifetime and 33% of women will develop symptoms from uterine fibroids, the committee noted.
They heard from clinical experts who noted that the benefit of linzagolix is the flexible dosing and that it can be used with or without additional hormone treatment.
It was not recommended for short-term use of less than six months, for example in patients who are taking treatment prior to surgery for their condition, because the committee was unable to determine if it was cost-effective in this population.
Some patients do not want surgery for various reasons including that they are trying to conceive, the committee said.
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.’
NICE recommendations on linzagolix
Linzagolix is recommended as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age only if:
- it is intended to be used for longer-term treatment (normally for more than 6 months and not for people who need short-term treatment, for example, before planned surgery)
- the following dosage is used:
- with hormonal add-back therapy (ABT): 200 mg once daily
- without hormonal ABT: 200 mg once daily for 6 months, then 100 mg once daily.
Source: NICE
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