Hungarian drug greenlighted for the EU

The Hungarian pharmaceutical company Gedeon Richter Plc. has announced that the European Commission has granted marketing authorization to Reagila® (cariprazine) a novel antipsychotic for the treatment of schizophrenia in adult patients. This decision is applicable for all member states in the European Union.

According to a statement by Richter., Cariprazine was discovered by Richter scientists and is licensed to Allergan in the U.S. and Canada. Following its FDA approval in September 2015, the product was launched in the U.S. in March 2016 under the trademark of Vraylar for the treatment of both schizophrenia and bipolar mania.

In August 2016, Richter and Recordati signed an exclusive license agreement to commercialize cariprazine in Western Europe, in Algeria, in Tunisia and in Turkey.

The European application for the treatment of schizophrenia includes results from three short-term, placebo and partly active controlled positive trials in over 1,800 patients and one long-term trial, using the change from baseline in the scale, assessing the severity of schizophrenia symptoms. A clinical trial with positive results was also carried out in patients suffering from predominant negative symptoms of schizophrenia.