Recordati reported European Commission approval of Gedeon Richter’s atypical antipsychotic Reagila® (cariprazine) for treating schizophrenia in adult patients. In August 2016, Recordati negotiated an exclusive license to commercialize the drug in Western Europe, Algeria, Tunisia, and Turkey.

EC approval of Reagila was based on data from three placebo- and partly active-controlled studies in over 1800 patients, and one long-term trial, which evaluated the drug’s effects on the severity of schizophrenia symptoms measured using the Positive and Negative Syndrome Scale (PANSS) total score and time to relapse. A study in patients with predominantly negative symptoms of schizophrenia was also successfully completed.

“We are very pleased with the European Commission's decision to authorize the marketing of cariprazine, a novel antipsychotic that represents an additional treatment option for patients suffering from schizophrenia, a complex condition for which a medical need for new treatment options persists,” commented Andrea Recordati, vice chairman and CEO. “We are extremely pleased to enter the segment dedicated to treatments for central nervous system disorders in which there is a continuing need for new and differentiated therapeutic solutions.

Cariprazine is an orally active dopamine D3//D2 receptor partial agonist with preferential binding to D3 receptors and a partial agonist at serotonin 5-HT1A receptors. The drug was originally discovered by scientists at Budapest-based Richter and was jointly developed with Allergan (previously Forest/Actavis) for bipolar mania and schizophrenia for the U.S. and Canadian markets. Cariprazine was approved for both indications by the FDA in 2015, and launched in the U.S. as Vraylar™ during the first half of 2016. Allergan and Richter are, in addition, developing cariprazine for treating bipolar depression, and as adjunctive therapy for major depressive disorder (MDD) in the U.S. In August last year, Allergan and Richter reported the failure of a Phase III study evaluating cariprazine as an adjunctive treatment to antidepressant therapy in adult MDD patients. At the time, the partners confirmed their commitment to developing the drug as a potential treatment option for MDD patients. 

Mitsubishi Tanabe Pharma is developing cariprazine for the treatment of schizophrenia in Japan and in other Asian countries.

Gedeon Richter manufactures more than 200 drugs, including original, generic, and licensed products. The firm’s R&D focus is on gynecological, cardiovascular, and central nervous system products. Gedeon Richter reported total sales of €1.3 billion (approximately $1.5 billion) in 2016, up 6.1% on 2015.