Janssen-Cilag International has been given the thumbs up by the European Commission for its antipsychotic drug Invega (paliperidone ER) – the first treatment for schizoaffective disorder in Europe.
The decision, which allows the drug to treat psychotic or manic symptoms, follows a positive recommendation by the European Medicine Agency’s Committee for Medicinal Products for Human Use that concluded the drug brings significant clinical benefit in comparison with existing therapies. However, the effect on depressive symptoms has not yet been demonstrated.
The approval is based on two international, randomised, double-blind, placebo-controlled six-week studies in patients diagnosed with schizoaffective disorder, which is a mental illness characterised by both symptoms of schizophrenia and a major mood disorder such as bipolar disorder or depression and is thought to be one-third as common as schizophrenia.
“These two studies combined represent the largest set of prospective data in patients with schizoaffective disorder and provide important insights into this understudied disease,” said Dr Carla Canuso, from Johnson & Johnson and lead investigator of the two studies. “Invega is proven to be effective both as a monotherapy and as a adjunctive therapy in reducing psychotic and manic symptoms and provides a welcome treatment option for this debilitating condition.”