EU Commission approves Reagila (cariprazine), for the treatment of schizophrenia .-Recordati + Gedeon Richter.
Recordati announces that Gedeon Richter Plc. was granted marketing authorization from the European Commission for Reagila (cariprazine), a novel antipsychotic for the treatment of schizophrenia in adult patients, valid for all European Union Member States.
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 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, i.e. 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.
The high relevance of these results is the base for a publication in The Lancet (Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial; The Lancet Volume 389, No. 10074, p1103�1113, 18 March 2017).
Comment:The drug is licensed to Allergan in Canada and the US, where it was approved by the FDA in 2015 under the brand name Vraylar for the treatment of both schizophrenia and bipolar mania.
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