The European Commission (EC) has granted marketing authorization for 5 mg tablets of Esmya, a drug developed by Preglem, a 100%-owned unit of Hungarian pharmaceutical company Gedeon Richter, for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids, Richter announced on Monday.
This decision follows positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 16, 2011 and is applicable for all European Union member states.
The approval is based on the assessment of extensive pre-clinical data, quality data, and clinical data, which include data from the two-phase III pivotal clinical studies, PEARL I and PEARL II.
Richter acquired PregLem, the Swiss pharmaceutical company that makes Esmya, in October 2010. As a result of the acquisition Richter procured the distribution and marketing rights for the drug in the European Union and in North America.