FDA approves Enbrel (etanercept) sBLA to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. -Amgen

Amgen has announced that the FDA has approved the supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis.

The approval is based on results from a Phase III one-year study and its five-year open-label extension study to evaluate the safety and efficacy of Enbrel in pediatric patients, ages 4 to 17, with chronic moderate-to-severe plaque psoriasis. In addition to demonstrating significant efficacy, the adverse events were similar to those seen in previous studies in adults with moderate-to-severe plaque psoriasis.