England’s NICE Approves Theramex’s Uterine Fibroids Treatment

Approval by NICE:
The National Institute for Health and Care Excellence (NICE) has approved linzagolix (sold as Yselty by Theramex) for treating moderate to severe symptoms of uterine fibroids.

Beneficiaries:
Up to 30,000 women in England are expected to benefit from this new treatment option.

Mechanism of Action:
Linzagolix is a GnRH antagonist that reduces the release of hormones controlling oestrogen and progesterone production, thereby reducing bleeding and shrinking fibroids.

Administration:
It is taken once a day as a single tablet and can be used with or without hormonal add-back therapy (ABT) to mitigate side effects and protect bone health.

Impact on Quality of Life:
Uterine fibroids can significantly affect quality of life, causing heavy menstrual bleeding, pelvic pressure, and pain. Linzagolix offers a more personalized treatment option, improving the management of these symptoms.

Prevalence:
Approximately 66% of women develop at least one uterine fibroid in their lifetime, with 33% experiencing symptoms.

NHS Availability:
The treatment will be available on the NHS for eligible women across England and Wales.

Clinical Trials:
Clinical trials have shown linzagolix to be effective in reducing fibroid-related bleeding and shrinking the fibroids compared to a placebo.

Expert Opinions:
Health experts and advocates have welcomed this decision, emphasizing the need for accessible and diverse treatment options for women, particularly those in communities with higher prevalence rates, such as Black women.