European Commission approves Gedeon Richter's Esmya type II Variation

The European Commission has granted marketing authorization to extend the use of Esmya (ulipristal acetate) tablets to up to two courses of three-month treatment of uterine fibroids, said the drug’s producer, Hungary’s largest drugmaker Gedeon Richter (RICHT: HB).

This decision follows positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on November 26, 2013 and is applicable for all Member States in the European Union.

Esmya 5mg tablets received a community Marketing Authorization on in February 2012, valid in the European Union member states, for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The duration of treatment was originally limited to three months. This EC approval now provides the basis for an extended use of Esmya 5mg, which allows one repeated course of three month treatment.