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Esmya® long-term indication in EU

Esmya® is approved in the European Union for long-term management of symptomatic uterine fibroids1.

  • Esmya® (Ulipristal acetate 5mg) is now indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age7.
  • The efficacy and safety of intermittent treatment with Esmya® has been confirmed in the recent PEARL III extension and PEARL IV studies 7,44.
  • Esmya® is effective for bleeding control and reduction in fibroid volume7.
  • Efficacy of Esmya® is maintained even during off-treatment periods and is well tolerated7.

Transforming uterine fibroid management with long-term use of Esmya®

Until now, uterine fibroids were commonly treated surgically with or without short-term pre-operative medical treatments with either SPRM (Ulipristal acetate 5mg – Esmya®) or GnRh-Agonists.

There was a growing demand from patients for a long-term medical treatment, as surgery may not be a suitable option for all of them, e.g. for medical or personal reasons or  in perimenopausal women who would rather wait for the symptoms of uterine fibroids decrease as result of menopause or women who are planning  to  become pregnant in the future.

Since 2015 Esmya® is approved  for the intermittent use in moderate to severe symptoms of uterine fibroids1 providing the first long-term medical treatment option for many women.

Esmya® is an oral selective progesterone receptor modulator (SPRM) that provides2:

  • Fast, reliable and sustained bleeding control7
  • Significant and sustained reductions in fibroid volume7
  • Improved quality of life, to the level of healthy subjects7
  • Efficacy on fibroid and associated symptom maintenance during off-treatment periods7
  • Safe treatment for long-term symptom management – repeated treatment courses did not increase the occurrence of adverse events7

Learn more about Esmya®’s clinical research and development



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