Two Johnson & Johnson subsidiaries, Centocor, Inc. and Janssen-Cilag International NV, have submitted marketing approval applications for ustekinumab (CNTO 1275) in the U.S. and Europe for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor has submitted a BLA wit the FDA and Janssen-Cilag International an MAA to the EMEA. 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, according to a joint statement.
It is estimated that 125 million people worldwide have psoriasis, including 2% of both the U.S. and European populations, or some 7.5 million Americans and 10 million Europeans. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.
"We are very encouraged by the promising results that we have seen through the ustekinumab clinical development program evaluating the efficacy and safety of this novel biologic in the treatment of moderate to severe plaque psoriasis," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc.