Janssen-Cilag schizophrenia drug receives EU marketing authorisation

Janssen-Cilag has announced that it will market Invega (paliperidone prolonged release tablets), following the granting of marketing authorisation for the drug from the European Medicines Agency.

The drug is designed to deliver its active ingredient paliperidone through the novel osmotic delivery system (Oros) and is approved following clinical trials showing its efficacy compared to placebo and toleration by patients.

Reporting this approval as a key landmark in the company’s commitment to develop new therapies for patients suffering serious mental illnesses, Janssen-Cilag notes that Invega is the first schizophrenia treatment using Oros to be approved for use in the European Union.

The company reports that the decision to grant marketing authorisation for the drug follows a number of successful clinical trials.

“The primary measure of efficacy was the Positive and Negative Syndrome Scale, a tool commonly used in schizophrenia research that measures the severity of positive and negative symptoms and general psychopathology,” Janssen-Cilag commented.

It added that other measures used in this trial included the Personal and Social Performance Scale used to assess functional improvement, in addition to tests of safety and tolerability.

Invega received a positive opinion as a treatment for schizophrenia from the European Committee for Human Medicinal Products in April 2007 after clinical studies involving over 1,600 patients.