EU approves Esmya (PregLem) for moderate to severe symptoms of Uterine Fibroids

The European Commission has granted marketing authorization to Esmya (ulipristal acetate), from PregLem, as pre-operative treatment of moderate to severe symptoms of Uterine Fibroids. This decision follows positive opinion from the CHMP of the European Medicines Agency on 16 December 2011 and is applicable for all Member States in the European Union. The approval is based on the assessment of extensive pre-clinical data, quality data, and clinical data involving 498 subjects treated with Esmya which include data from the two Phase III pivotal clinical studies, PEARL I and PEARL II. Esmya is a orally active, selective progesterone receptor modulator. There are no data available on treatment with duration longer than 3 months.