Janssen, a Johnson & Johnson company, announced that it has submitted a supplemental Biologics License Application to the United States Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency requesting approval of Stelara (ustekinumab) for the treatment of adults with active psoriatic arthritis. Stelara is a human interleukin (IL-12 and IL-23) antagonist. IL-12 and IL-23 are naturally-occurring cytokines thought to be associated with immune-mediated inflammatory diseases.
Stelara was approved by the FDA in 2009 for the treatment of moderate to severe plaque psoriasis in adults. The drug is currently approved in 69 countries for the treatment of plaque psoriasis. The applications requesting approval of Stelara for psoriatic arthritis are backed by Phase III clinical trials that evaluated the safety and effectiveness of 45 mg. and 90 mg. Stelara administered by subcutaneous injection.
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