Nov. 4, 2016
Amgen has 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). This makes it the first and only systemic therapy for treating pediatric patients of ages 4 to 17 with chronic moderate-to-severe plaque psoriasis.
Randy Beranek, president and chief executive officer of the National Psoriasis Foundation, said: “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. 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 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. 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,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.