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.