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Published on 20 June 2008

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FDA committee recommends ustekinumab approval

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Centocor, Inc has announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the US Food and Drug Administration (FDA) has unanimously recommended the approval of 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.

“We are very pleased with the advisory committee’s support for the approval of ustekinumab,” stated Jerome A. Boscia, MD, 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 III multicentre, randomised, 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 medical journal 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. The final decision on approval of the drug will be made by the FDA.

Johnson and Johnson



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