FDA Approves Treatment for Psoriatic Arthritis for Pediatric Patients 6 Years and Older – Drug Information Update

CENTER FOR DRUG EVALUATION AND RESEARCH DIVISION of DRUG INFORMATION Your source for the latest drug information. Know the moment it happens. FDA Approves Treatment for Psoriatic Arthritis for Pediatric Patients 6 Years and Older FDA has expanded the use of Stelara (ustekinumab) injection for subcutaneous use to treat pediatric patients 6 years and older with psoriatic arthritis (PsA). Stelara was approved for the same indication for adults in 2013.  Serious infections, hypersensitivity reactions, noninfectious pneumonia, and other conditions have been reported with use of Stelara.  Use of Stelara among patients ages 6 to 17 is supported by evidence from adequate and well controlled studies of Stelara in adults with psoriasis and PsA; pharmacokinetic data from adult patients with psoriasis, adult patients with PsA, and pediatric patients with psoriasis; and safety data from two clinical studies in 44 pediatric patients 6 to 11 years old with psoriasis and 110 pediatric patients 12 to 17 years old with psoriasis.  Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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