FDA approves Amgen’s Enbrel to treat children with plaque psoriasis

The approval of the company’s supplemental Biologics License Application makes it the first and only systemic therapy to treat pediatric patients aged 4 to 17 affected by the severe inflammatory disease.

Results of a phase 3 one-year study and its five-year open-label extension study to determine the safety and efficacy of etanercept in pediatric patients aged 4 to 17 years with chronic moderate-to-severe plaque psoriasis were the basis of the FDA’s approval.

It demonstrated significant efficacy, with adverse events similar to those seen in earlier studies of adults with moderate-to-severe psoriasis.

Amgen executive vice president of research and development Sean Harper said: "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.”

Enbrel is a soluble form of a tumor necrosis factor receptor with a clinical efficacy and safety profile established over 15 years of collective clinical experience, Amgen said.

It was initially approved in 1998 for moderate-to-severe rheumatoid arthritis. In 2004, the FDA approved Enbrel to treat moderate-to-severe plaque psoriasis in adults.

Image: Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.