Approved: First Rx for Plaque Psoriasis in Children

Amgen's Enbrel (etanercept) approved by FDA to treat plaque psoriasis in children

(RxWiki News) The first-ever medication to treat plaque psoriasis in children has been approved.

The US Food and Drug Administration (FDA) has expanded the use of Enbrel (etanercept) to treat children ages 4 to 17 who have moderate to severe chronic plaque psoriasis.

Etanercept is available as an injection to be given under the skin every week.  

"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," said Randy Beranek, president and CEO of the National Psoriasis Foundation, in a press release from Amgen, which manufactures Enbrel. "Until now, no biologics — which are effective in treating adults with moderate to severe plaque psoriasis — had been approved in the US for the treatment of moderate to severe plaque psoriasis in children."

This recent approval is based on the results of a Phase III clinical trial that assessed the safety and effectiveness of this medication in children. Patients in this study were between the ages of 4 and 17 and had moderate to severe chronic plaque psoriasis. 

Common side effects of this medication include sinus infections and injection-site reactions like swelling, redness, itching or pain. 

Etanercept works on the immune system. As a result, it may make it harder to fight infections. In fact, this medication has a boxed warning regarding the increased risk of serious infections, including tuberculosis (TB). 

Etanercept also has a boxed warning about cases of cancers that have been reported in children and teenagers.

Last Updated:
November 8, 2016