J&J Seeks European Approval for Schizophrenia Drug
Posted on: Monday, 8 May 2006, 12:04 CDT
Johnson & Johnson, via its subsidiary Janssen-Cilag, has filed an application to European regulators seeking approval to market its prolonged release schizophrenia drug, paliperidone prolonged release tablets.
Paliperidone, which releases drug into the bloodstream steadily over a 24-hour period, is an extended release version of Johnson & Johnson's blockbuster schizophrenia treatment Risperdal.
The paliperidone filing is based on a global clinical development program that involved more than 1,600 patients in 23 countries. Regulatory submissions for the drug have already been filed in the US, with other regions of the world expected to follow.
"Enhancing patient care for people with schizophrenia is something we strive for every day as physicians treating this illness," said Dr Andreas Heinz, director of the department of psychiatry at Charite University Medical Center, Berlin. "We hope more options become available to meet the needs of patients with this complex and debilitating disease."
Upon approval, paliperidone will be marketed in Europe by the Janssen-Cilag companies.
Source: Datamonitor
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