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Advisory Committee Recommends Approving Ustekinumab for Treatment of Moderate-to-Severe Plaque Psoriasis
"We are very pleased with the advisory committee's support for the approval of ustekinumab," stated Jerome A. Boscia, M.D., Senior Vice President, Clinical, Centocor R&D. "For many patients, psoriasis is a serious disease, and they are in need of additional treatment options. It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make ustekinumab available to patients with moderate to severe psoriasis."
The committee reviewed data from one of the largest biologic clinical programs in psoriasis, which included two large Phase 3 multicenter, randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of ustekinumab involving more than 2,000 patients. Results of these Phase 3 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 U.S. 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.
Ustekinumab is a new, human monoclonal antibody in Phase 3 development by Centocor, Inc. for the treatment of moderate to severe plaque psoriasis, and is being investigated as an infrequently administered subcutaneous injection. Ustekinumab is a novel biologic therapy that targets interleukin 12 (IL-12) and interleukin 23 (IL-23), naturally occurring proteins that are important in regulating the immune system and that are also believed to play a role in psoriasis.