This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), announced on May 19, and is applicable for all member states in the European Union.
Cariprazine was discovered by Richter scientists and is licensed to Allergan (earlier Forest/Actavis), in the United States and Canada. Following its FDA approval in September 2015, the product was launched in the States in March 2016 under the trademark of VRAYLARTM, 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, Algeria, Tunisia and Turkey.
The European application for the treatment of schizophrenia includes results from three short-term, placebo and partly active controlled positive trials in more than 1,800 patients and one long-term trial, using the change from baseline in the scale, assessing the severity of schizophrenia symptoms, i.e. the Positive and Negative Syndrome Scale (PANSS) total score and the time to relapse as primary efficacy endpoints, respectively, Gedeon Richter explains. A clinical trial with positive results was also carried out in patients suffering from predominant negative symptoms of schizophrenia.
“This approval is a result of the outstanding work accomplished by our team. We are delighted to bring the benefits of Reagila® (cariprazine) to patients and physicians in the EU as an additional option for the treatment of schizophrenia,” said Erik Bogsch, managing director of Gedeon Richter Plc. “This approval reinforces our deep commitment to improve the quality of life for patients suffering from this serious mental condition.”
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