EMA begins evaluation of Richter’s cariprazine
The European Medicines Agency (EMA) accepted Hungarian drugmaker Gedeon Richter’s regulatory submission for cariprazine, a novel antipsychotic for the treatment of schizophrenia in adult patients, Richter announced today.
Following its FDA approval in September 2015, the product was recently launched in the United States under the trademark VRAYLARTM for the treatment of both schizophrenia and bipolar mania, the press release by Richter noted.
Cariprazine was discovered by Richterʼs scientists and is licensed to Allergan (earlier Forest/Actavis), in the United States and Canada.
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 Positive and Negative Syndrome Scale (PANSS) total score and the time to relapse as primary efficacy endpoints, Richter said. A clinical trial with positive results was also carried out in patients suffering from predominant negative symptoms of schizophrenia, the company added.
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