US Pharm. 2016;41(12):12.
Silver Spring, MD—The FDA has approved expanded use of etanercept (Enbrel) to treat pediatric patients (aged 4-17 years) with chronic moderate-to-severe plaque psoriasis. It is the first and only systemic drug approved in the United States to treat children affected by this serious inflammatory disease. The approval is based on results from a phase III, 1-year trial and its 5-year open-label extension study. Besides the significant efficacy demonstrated by the drug, the adverse events were similar to those seen in previous studies in adult psoriasis patients. “This new approval is an important development for this patient community, as well as their parents and families, and marks a significant milestone in advancing the treatment of children living with this devastating disease,” said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation.
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