Johnson & Johnson's Invega first antipsychotic for schizoaffective disorder approved in EU

Belgium-based Janssen-Cilag International, part of US health care giant Johnson & Johnson (NYSE: JNJ), yesterday received approval from the European Commission for the first antipsychotic treatment for schizoaffective disorder. The drugmaker’s Invega (paliperidone ER) is now indicated for the treatment of psychotic or manic symptoms of schizoaffective disorder. Effect on depressive symptoms has not been demonstrated.

The decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency. The CHMP concluded that the new therapeutic indication for Invega brings significant clinical benefit in comparison with existing therapies. The drug was approved in the European Union for the treatment of schizophrenia in 2007.

Schizoaffective disorder is a chronic and disabling mental illness, characterized by both symptoms of schizophrenia and a major mood disorder, such as bipolar disorder or depression. Patients may experience the clinical symptoms of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression. Schizoaffective disorder is thought to be one-third as common as schizophrenia, with an estimated prevalence of around one in every 300 people. Schizoaffective disorder may also account for up to one-quarter of admissions to inpatient mental health facilities, the company noted.