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Janssen-Cilag reports positive opinion for schizophrenia drug
Janssen-Cilag, a Johnson & Johnson subsidiary, has announced that Invega (paliperidone prolonged release tablets) has received a positive opinion as a treatment for schizophrenia from the European Committee for Human Medicinal Products (CHMP).
The application for marketing approval in Europe follows clinical studies in 23 countries involving over 1,600 patients, with Janssen-Cilag predicting the receipt of authorisation for the compound by the middle of this year.
Invega was developed by Johnson & Johnson Pharmaceutical Research and Development and uses Oros extended-release technology developed by Alza to smooth blood plasma levels through unique medication-release over 24 hours.
When approved for use in Europe, the compound will be marketed in the European Union by Janssen-Cilag companies.
Professor Andreas Heinz, director at the department of psychiatry at Charite University Medical Centre, said: “I am pleased to learn that paliperidone prolonged release tablets have received a positive opinion from the CHMP, because we still need more treatment options for schizophrenia.”
He added that clinical research had shown the treatment exhibiting positive efficacy and tolerability in addition to an improvement in patient functioning.
Earlier this month, Janssen announced the US availability of a new formulation of Risperdal Consta (risperidone) as a treatment option for schizophrenia patients suffering from conditions including hepatic and renal impairment.
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