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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

"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 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.