Amgen (AMGN) Receives FDA Approval for ENBREL sBLA as Expanded Indication

November 7, 2016 7:30 AM EST

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Amgen (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (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.

"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. 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," said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation. "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."

The approval 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, 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.

"The need for an effective treatment for chronic moderate-to-severe pediatric psoriasis patients is high, and safety is always a concern when it comes to treating children. ENBREL has over a decade of experience in adult moderate to severe plaque psoriasis, and that proven track record matters to healthcare professionals, as well as the parents of children with moderate-to-severe plaque psoriasis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today's FDA approval shows that innovation doesn't stop with a drug's first market approval, and further reflects Amgen's commitment to continually unlock and expand the therapeutic potential of our medicines in the hopes of filling unmet patient needs."

Learn more about this expanded use of ENBREL at www.enbrel.com or by calling 1-888-4ENBREL.



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