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news.Centocor, a subsidiary of J&J, has announced that the dermatologic and ophthalmic drugs advisory committee of the 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.
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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 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.
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.
Jerome Boscia, senior vice president, clinical, Centocor R&D, said: “We are very pleased with the advisory committee’s support for the approval of ustekinumab. 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.”