Uterine fibroid treatment could reduce need for surgery
New development in treatment of uterine fibroids could enable thousands of women to avoid hysterectomies
A new development in the treatment of uterine fibroids that could enable thousands of women to avoid hysterectomies and other major surgery has been authorised by the European Commission.
Ulipristal acetate (Esmya®) is an oral treatment for the moderate to severe symptoms of uterine fibroids in adult women of reproductive age, that gives rapid control of uterine bleeding, reduces anaemia and shrinks the size of fibroids.
Until now, ulipristal acetate could only be used as a pre-operative treatment of moderate to severe symptoms of uterine fibroids, with women being able to take the drug prior to a surgical procedure.
Esmya – taken as a once-daily tablet – has now been authorised by the European Commission so it can be taken on an intermittent basis, giving women the opportunity to opt for long-term medical management of uterine fibroids and potentially avoid surgery.
Around 40 in every 100 women develop uterine fibroids at some time in their life and it is estimated that about 300,000 surgical procedures are performed annually in the EU for fibroids, including approximately 230,000 hysterectomies.
The authorisation for ulipristal acetate to be used without surgery follows two long-term phase III clinical studies, involving 132 and 451 patients, which assessed the efficacy and safety of intermittent use. Efficacy was demonstrated by a reduction in bleeding, fibroid volume and pain, and ultimately an improvement in the quality of life of women suffering from symptomatic uterine fibroids.
The authorisation has been welcomed by clinicians, who believe it could transform the way uterine fibroids are treated.
Martin Powell, consultant gynaecologist in Nottingham, said: “This development is a significant advancement in the treatment of uterine fibroids, as many women will now be able to take Esmya to shrink their fibroids and reduce the bleeding, rather than having to undergo major surgery, which can in some severe cases be life-threatening.
“It is particularly significant for those women who want children and therefore wish to avoid surgery that could damage their fertility or, in the case of a hysterectomy, prevent them being able to start a family.”