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European Medicines Agency forms positive opinion on PregLem drug

Hungarian drugmaker Gedeon Richter on Friday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion for a trademarked drug for the treatment of uterine fibroids made by its wholly-owned unit PregLem.

Richter said PregLem was expected to receive a marketing authorisation for the drug, called Esmya, valid for all European Union member states in early 2012, subject to approval by the European Commission.

"Esmya is the first new treatment to be launched for that condition in more than 20 years. The positive CHMP opinion confirms Esmya therapeutic potential and is an important milestone towards making Esmya available for addressing the unmet medical needs of women with uterine fibroids", said PregLem CEO Dr. Ernest Loumaye, Chief Executive Officer of PregLem.