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news.Centocor has said that the biologics license application or BLA for ustekinumab has been accepted for review by the FDA for the treatment of adult patients with chronic moderate to severe plaque psoriasis.
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Centocor has submitted the BLA for ustekinumab (CNTO 1275) in December 2007 based on its development program including data from two large phase III multicenter, randomized, double-blind, placebo-controlled trials involving nearly 2,000 patients that evaluated the safety and efficacy of ustekinumab.
Jerome Boscia, senior vice president, clinical R&D, Centocor, said: “We are pleased by the FDA’s acceptance of our biologics license application for review of ustekinumab. Ustekinumab has yielded promising efficacy and safety results in phase III clinical trials, and we look forward to working closely with the FDA during their ongoing review of this potential new treatment for psoriasis.”