J-C submits paliperidone MAA to EMEA

Belgian drugmaker Janssen-Cilag, a subsidiary of healthcare major Johnson & Johnson, says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for its developmental prolonged-release schizophrenia drug paliperidone. The compound, which uses the firm's OROS technology, is designed to be released into a patient's bloodstream steadily, over a 24 hour period.

The submission is based on data from an extensive clinical development program, which examined the product's use by more that 1,600 patients in 23 countries. The firm added that it filed a New Drug Application for the product with the US Food and Drug Administration late last year (Marketletter December 12, 2005) and said that it will file further applications with regulatory authorities around the world in due course. The company went on to say that, if approved, the extended release once-daily, oral treatment should enhance the therapy adherence rates, which is usually low for schizopheric patients.