Centocor, Janssen-Cilag Submit Ustekinumab Applications

Centocor and Belgian drugmaker Janssen-Cilag International have submitted applications requesting the approval of ustekinumab in the U.S. and Europe for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

Ustekinumab is a human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 and interleukin-23, which are thought to be associated with certain inflammatory disorders, including psoriasis.

The submissions include data from two multicenter, randomized, double-blind, placebo-controlled Phase III trials involving approximately 2,000 patients, Centocor said.