FDA approves sBLA to expand Enbrel indication

The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) from US biotech giant Amgen (Nasdaq: AMGN) for the expanded use of Enbrel (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages four-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 USA for the treatment of moderate-to-severe plaque psoriasis in children," said Randy Beranek, president and chief executive 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 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 Dr Sean Harper, executive vice president of R&D at Amgen, adding: "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."