CHMP recommends Esmya (PregLem) for pre-operative treatment of Uterine Fibroids

The CHMP has issued a positive recommendation for Esmya (ulipristal acetate) from PregLem ( a subsidiary of Gedeon Richter), for pre-operative treatment of symptoms of uterine fibroids in adult women. Esmya is a pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Treatment is limited to three months because there are no data available yet on longer treatment durations or on repeat courses of treatment. It is a selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect. It acts by depriving uterine fibroids of growth stimulation due to progesterone and its benefits include reduction of fibroid-related bleeding, anaemia and fibroid size.