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Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's supplemental Biologics License Application (sBLA) for the expanded use of Enbrel® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis.
The sBLA, submitted on Jan. 5, 2016, is based on results from a Phase 3 one-year study and its five-year open-label extension study to evaluate the safety and efficacy of ENBREL in pediatric patients with moderate to severe plaque psoriasis.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 5, 2016, for the ENBREL sBLA application.
