Centocor has submitted a biologics license application with the FDA and Janssen-Cilag International has submitted a marketing authorization application to the European Medicines Agency.
The submissions are based on a comprehensive development program including data from two large Phase III multicenter, randomized, double-blind, placebo- controlled trials involving nearly 2,000 patients that evaluated the safety and efficacy of ustekinumab in the treatment of moderate to severe plaque-type psoriasis. The primary endpoint of each pivotal study was the proportion of patients who achieved at least a 75% reduction in psoriasis as measured by the psoriasis area and severity index (PASI 75).
Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis.
Jerome Boscia, senior vice president, clinical R&D, Centocor, said: “We remain committed to developing safe and effective new therapies for patients with inflammatory diseases like psoriasis through continued research and development in disease areas where unmet needs in treatment remain.”