CHMP issues positive opinion for Richter’s cariprazine
Image by LaMography/Moni Lazar
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on Hungarian drugmaker Gedeon Richter’s application for cariprazine, a novel antipsychotic for the treatment of schizophrenia in adult patients, according to a press release sent to the Budapest Business Journal on Friday.
The marketing authorization application was submitted to the EMA in March 2016. Subject to approval by the European Commission, Richter is expected to receive a marketing authorization for cariprazine in two months valid for all EU member states, according to the company.
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 America in March 2016 under the trademark 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, Algeria, Tunisia and Turkey.
According to the press release, the European application for the treatment of schizophrenia includes results from three short-term, placebo and partly active controlled positive trials on 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. A clinical trial with positive results was also carried out in patients suffering from predominant negative symptoms of schizophrenia.
“We are very pleased with the CHMP positive opinion of cariprazine, which is considered as a significant milestone for Richter’s original research program,” said Erik Bogsch, managing director of Gedeon Richter Plc. “Although there are various treatment options available for patients living with schizophrenia, medical needs persist, therefore we remain committed to offer an additional treatment option for patients suffering from this complex condition,” he added.
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