Centocor has filed an application with the U.S. Food and Drug Administration (FDA) seeking approval of its experimental treatment ustekinumab (previously known as CNTO 1275) for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor’s Biologics License Application (BLA) submission means that FDA approval of ustekinumab for psoriasis could come as early as 2008. Ustekinumab has, to date, shown strong results with impressive safety in clinical trials.
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,” the company said in a statement.
Also today, Janssen-Cilag International NV, which owns the marketing rights for ustekinumab outside of the U.S., filed for European approval of the treatment.
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