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FDA approves Enbrel to treat children with plaque psoriasis
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The FDA has approved Amgen’s supplemental biologics license application for expanded use of Enbrel for treating pediatric patients aged 4-17 years with chronic moderate-to-severe plaque psoriasis, according to a press release from the drug’s manufacturer.
The FDA’s action makes Enbrel (etanercept) the first and only systemic therapy to treat pediatric patients with the condition, according to the release.
“As many parents of children with moderate-to-severe plaque psoriasis can tell you, there is a need for FDA-approved systemic therapies in the pediatric setting,” Randy Beranek, president and CEO of the National Psoriasis Foundation, stated in the release. “Until now, no biologics – which are effective in treating adults with moderate-to-severe plaque psoriasis – had been approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in children. 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.”
Results of a phase 3 1-year study and its 5-year open-label extension study to evaluate the safety and efficacy of etanercept in pediatric patients aged 4 to 17 years with chronic moderate-to-severe plaque psoriasis were the basis of the FDA’s approval, according to the release. The studies demonstrated significant efficacy, with adverse events similar to those seen in previous studies of adults with moderate-to-severe psoriasis, the release reported.
The FDA approved Enbrel for treating moderate-to-severe plaque psoriasis in adults in 2004, according to the release.
Reference: www.amgen.com