Gedeon Richter's new schizophrenia drug approved in Europe

19 July 2017

Hungary’s largest drugmaker Gedeon Richter (RICHT: HB) has been granted marketing authorization from the European Commission for Reagila (cariprazine), a novel antipsychotic for the treatment of schizophrenia in adult patients.

In August 2016, Richter and Recordati (RECI: MI) signed an exclusive license agreement for the Italian pharmaceutical company to commercialize cariprazine in Western Europe, Algeria, Tunisia and Turkey.

The European application for the treatment of schizophrenia included results from three 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, ie, the Positive and Negative Syndrome Scale (PANSS) total score and the time to relapse as primary efficacy endpoints, respectively. A clinical trial with positive results was also carried out in patients suffering from predominant negative symptoms of schizophrenia.

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