Firm claims atypical antipsychotic drug is the first to be approved in Europe for this indication.
The EC approved the Johnson & Johnson firm Janssen-Cilag’s atypical antipsychotic drug Invega® (paliperidone ER) extended-release tablets for treating the psychotic or manic symptoms of schizoaffective disorder. Invega was first approved in Europe in 2007 for the treatment of schizophrenia.
The latest regulatory clearance in Europe was based on data from two international, placebo-controlled six-week studies in schizoaffective disorder patients. The trials showed that in comparison with placebo, treatment with Invega significantly improved symptoms, as measured by the positive and negative syndrome scale (PANSS). Janssen says the drug is the first to have been approved in Europe for treating schizoaffective disorder.
“These two combined represent the largest set of prospective data in patients with schizoaffective disorder,” comments lead investigator of the trials Carla M. Canuso, M.D., at Johnson & Johnson Pharmaceutical Research and Development. “Invega was proven to be effective both as monotherapy and as an adjunctive therapy in reducing psychotic and manic symptoms.”
Invega was cleared by FDA in 2006 for the treatment of schizophrenia, and in 2009 for the schizoaffective disorder indication. A once-monthly injectable formulation of the drug, Invega Sustenna™, was sanctioned by FDA in 2009 for the acute and maintenance treatment of schizophrenia.