The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the US Food and Drug Administration (FDA) has unanimously recommended the approval of Centocor’s ustekinumab, a new subcutaneous, investigational biologic therapy for the treatment of adult patients with moderate to severe plaque psoriasis.
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 the body's regulation of immune responses and that are also believed to play an important role in psoriasis.
The committee reviewed data from one of the largest biologic clinical programs in psoriasis, which included two large phase III multicenter, randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of ustekinumab involving more than 2,000 patients. Results of these phase III trials were recently published in The Lancet, which showed that a majority of patients treated with ustekinumab experienced significant skin clearance by week 12 and sustained efficacy through at least week 76 with ustekinumab maintenance therapy every 12 weeks. In December 2007, Centocor announced that a Biologics License Application had been submitted to the FDA.
DODAC is convened on request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of dermatologic and ophthalmologic conditions. The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.
Psoriasis is a chronic, immune-mediated disease, caused by the overproduction of skin cells, resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that 125 million people worldwide have psoriasis, including two percent of both the US 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.