Janssen-Cilag International’s Invega (paliperidone ER) has received the European Commission’s approval to extend its adult indication for treatment of schizophrenia to include adolescents aged 15 years and older.
Janssen-Cilag claims that Invega is the only antipsychotic currently licensed for the treatment of schizophrenia and schizoaffective disorder. Invega is indicated for the treatment of psychotic or manic symptoms of schizoaffective disorder in adults.
The European Commission has approved the extension for Invega following the Committee for Medicinal Products for Human Use of the European Medicines Agency’s positive opinion in April.
Invega has been approved by the European Commission based on positive data from three pivotal Phase III studies in adolescents.
Results from the three pivotal Phase III studies demonstrated that paliperidone ER has a safety and efficacy profile in adolescents similar to that observed in adults with schizophrenia.
Invega 3mg, 6mg and 12mg once-daily dose strengths resulted in improvements in symptoms of schizophrenia in adolescents in the first six-week double-blind, placebo-controlled study.
A Phase III study, which is extension to the first study, showed the tolerability and efficacy of flexibly dosed Invega in maintaining symptom stability for schizophrenia over the two year treatment period in this patient population.
The third Phase III study assessed the safety, efficacy and tolerability of Invega relative to oral aripiprazole, another antipsychotic licensed for the treatment of adolescent schizophrenia.
Results from the double-blind study showed a robust and clinically relevant improvement with Invega in symptom and functional measurements. The study has also demonstrated a tolerability profile similar to that observed in an adult population.