J&J’s Janssen Seeks EU OK for Long-Acting Schizophrenia Drug
Janssen-Cilag International NV has submitted an extension marketing authorization application to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three months formulation for the treatment of schizophrenia.
Paliperidone palmitate once-monthly (marketed as Xeplion in the European Union) is an atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries. Paliperidone palmitate once-every three- months formulation obtained priority review by the US Food and Drug Admnistration and is currently approved and launched in the US and marketed as Invega Trinz for patients previously treated with the once-monthly formulation. It contains the same active substance as Xeplion but with an extended dosing interval. If approved, it will be marketed as Trevicata in Europe.
Source: Johnson & Johnson