INVEGA granted positive opinion recommending approval in Europe

Apr 30 2007

Janssen-Cilag International NV has announced that the Committee for Human Medicinal Products (CHMP) in the European Union, has granted a positive opinion recommending approval of INVEGA (paliperidone prolonged release tablets).

INVEGA(R) is a new, once-daily, prolonged release oral medication, for the treatment of schizophrenia.

The CHMP is the committee responsible for the scientific assessment of products seeking one centralised marketing authorisation applicable throughout the European Union. Janssen-Cilag anticipates receiving the Marketing Authorisation from the European Commission by mid-year 2007.

The recommended indication is: "Paliperidone prolonged release tablets is indicated for the treatment of schizophrenia".

The paliperidone prolonged release tablets marketing authorisation application is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries. Paliperidone prolonged release tablets uses the OROS extended-release technology developed by ALZA Corporation. This technology is designed to release medication in a uniquely designed pattern over a 24-hour period, leading to smooth blood plasma levels.

"I am pleased to learn that paliperidone prolonged release tablets has received a positive opinion from the European Committee for Human Medicinal Products, because we still need more treatment options for schizophrenia. In clinical trials, paliperidone prolonged release tablets has demonstrated good efficacy and favourable safety and tolerability. Importantly, paliperidone prolonged release tablets also showed significant improvement in patient functioning and that is an important aspect in the treatment of schizophrenia," said Professor Andreas Heinz, M.D., Director, Department of Psychiatry, Charite University Medical Center CCM, Berlin, Germany.

As with all medications, patients may experience certain side effects that must be weighed against potential benefits when considering taking INVEGA(R).

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. It is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganised thinking.

Paliperidone prolonged release tablets was developed by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD). INVEGA(TM) has been approved by the Food and Drug Administration since December 2006 and is marketed by Janssen, L.P. in the United States. Upon approval by the European Commission, paliperidone prolonged release tablets will be marketed in Europe by the Janssen-Cilag companies.