Centocor's psoriasis drug accepted for FDA review

USA-based Centocor's Biologics License Application for ustekinumab (CNTO 1275) has been accepted for review by the Food and Drug Administration for the treatment of adult patients with chronic, moderate-to-severe plaque psoriasis.

Centocor, a subsidiary of global health care major Johnson & Johnson, says that ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 and 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.

Following its anticipated approval in early 2009, many industry observers feel ustekinumab will become the clinical gold standard for psoriasis. A recent report from Decision Resources stated that it will be the top selling drug for the skin disease by 2011 because of its competitive advantages in long-term efficacy over Centocor/Schering-Plough/Mitsubishi Tanabe's Remicade (infliximab) and due to its superior effect on plaque clearance when compared to Amgen/Wyeth/Takeda's Enbrel (etanercept; Marketletter February 18).