EU approves extension of approval for Invega for Schizophrenia - Janssen-Cilag

Janssen-Cilag International NV announced that the European Commission has approved an extension of the oral atypical antipsychotic Invega (paliperidone ER) Schizophrenia indication, to include adolescents aged 15 years and older. The decision from the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2014.

The approval is based on results from three pivotal Phase III studies with Invega in adolescents. Results showed that Invega has a safety and efficacy profile in adolescents similar to that observed in adults with schizophrenia. In the first, a six-week, randomised, double-blind, placebo controlled study, Invega 3 mg, 6 mg and 12 mg once daily dose strengths resulted in improvements in symptoms of schizophrenia in adolescents. As an extension to this study, a large two-year open label multicentre Phase III study, demonstrated the tolerability and efficacy of flexibly dosed Invega. The data also support the efficacy of the drug in maintaining symptom stability for Schizophrenia over the two year treatment period in this patient population.