Johnson & Johnson’s Janssen-Cilag has been given the go-ahead by regulators in Europe to sell Invega, the follow-up to its schizophrenia blockbuster Risperdal.
The European Commission has granted marketing authorisation for Invega (paliperidone) extended-release tablets, an atypical antipsychotic once-daily medication derived from Risperdal (risperidone) and J&J noted that the drug is delivered via the osmotic delivery system, which was developed by Alza Corp. The approval is based on a clinical programme that included three six-week, placebo-controlled clinical studies involving more than 1,600 patients with acute schizophrenia in 23 countries and a 40-week double blind, placebo-controlled study in 207 randomised patients.
The US Food and Drug Administration approved Invega (paliperidone), the first new schizophrenia drug to be approved since 2003, at the end of last year and J&J hopes that the compound will help maintain its leading position in that market as its Risperdal franchise starts to lose patent protection.
However Invega has not got off to the best start in the USA and analysts believe that J&J is still having trouble making a convincing case for the drug and whether taking it offers more benefits over Risperdal. Also, J&J has complained in the past that insurance companies in the USA have been placing too many restrictions on covering Invega.