A new treatment that could help women avoid surgery for uterine fibroids has been granted marketing authorisation by the European Commission.
The drug – ulipristal acetate – is already used to reduce symptoms prior to surgery but has now been given extended authorisation for the long-term management of uterine fibroids.
The move comes after intermittent use of the drug – brand name Esmya – was shown to reduce fibroid volume, pain and bleeding. In one study, four treatment courses of a 5mg daily dose taken for three months led to a median 70% reduction in fibroid volume, and 70% of women were in amenorrhea. The drug also resulted in reduced pain and improved quality of life during off-treatment phases.
It is hoped that the new indication could prevent women having to undergo hysterectomies and other major surgery.
Mr Martin Powell, consultant gynaecologist at Nottingham University Hospitals Trust, 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.’