Posted by Michael Wonder on 19 Jul 2017
European CHMP issues positive opinion for cariprazine for the treatment of schizophrenia
19 July 2017 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion on the company's application for cariprazine, a novel antipsychotic for the treatment of schizophrenia in adult patients.
The marketing authorisation application has been submitted to EMA in March 2016. Subject to approval by the European Commission, Richter is expected to receive in two months a marketing authorisation for cariprazine valid for all European Union Member States.
Cariprazine was discovered by Richter scientists and is licensed to Allergan (earlier Forest / Actavis), in the U.S. and Canada. Following its FDA approval in September 2015, the product was launched in the U.S. in March 2016 under the trademark of Vraylar for the treatment of both schizophrenia and bipolar mania. In August 2016 Richter and Recordati signed an exclusive license agreement to commercialise cariprazine in Western Europe, in Algeria, in Tunisia and in Turkey.
