Centocor, Inc (HORSHAM, Pennsylvania) announced that the Biologics License Application (BLA) for ustekinumab (CNTO 1275), a fully-human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, has been accepted for review by the US FDA for the treatment of chronic moderate-to-severe plaque psoriasis in adults. Acceptance of the BLA filing does not mean that a license has been issued for this product nor does it represent any evaluation of the data's adequacy. Newly presented were 1-year findings from one of two phase III multicenter, randomized, double-blind, placebo-controlled trials at the recent annual meeting of the American Academy of Dermatology.

Centocor submitted the BLA for ustekinumab in December 2007 based on its comprehensive development program including data from the two large trials involving ~2000 patients evaluating the safety and efficacy of ustekinumab in moderate-to-severe plaque psoriasis. The primary endpoint of both studies 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).

In December 2007, the Marketing Authorization Application for the compound was submitted by Janssen-Cilag Intl NV in Europe and is currently under review by the European Medicines Agency. Centocor and the Janssen-Cilag companies are members of the Johnson & Johnson family of companies. Centocor discovered ustekinumab and has exclusive marketing rights in the US, and the Janssen-Cilag companies have exclusive marketing rights in all countries outside of the US.