The FDA has approved the supplemental biologics license application for the expanded use of Enbrel (etanercept).
The FDA has approved the supplemental biologics license application for the expanded use of Enbrel (etanercept). Enbrel is the first and only systemic therapy to treat children aged 4 to 17 years for chronic moderate to severe plaque psoriasis.
Enbrel is a soluble form of a tumor necrosis factor receptor that was approved in 2004 to treat moderate to severe plaque psoriasis in adults.
The approval is based on results from a phase 3, 1-year study and a 5-year open-label extension study that evaluated the safety and efficacy of Enbrel in pediatric patients. The results showed significant efficacy and demonstrated adverse events similar to those seen in previous studies with adults.
“Until now, no biologics—which are effective in treating adults with moderate to severe plaque psoriasis—had been approved in the US for treatment of moderate to severe plaque psoriasis in children,” said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation, in a press release. “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.”