The FINANCIAL — Amgen on March 10 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.
“If approved, ENBREL would be the first systemic drug approved in the U.S. to treat chronic severe plaque psoriasis in pediatric patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We hope to be able to provide pediatric patients with an important new treatment option where there is a clear unmet medical need.”
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, according to Amgen.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 5, 2016, for the ENBREL sBLA application.
Discussion about this post