PhotoOf the 125 million people worldwide who suffer from psoriasis, approximately one-third are children. But the lack of FDA-approved treatment options has made treating cases of psoriasis in pediatric patients an uphill battle for many parents.

Now, the FDA has approved the expanded use of Enbrel to treat cases of chronic moderate-to-severe plaque psoriasis in children ages 4 to 17.
 

Previously, treatment options consisted of antihistamines and topical treatments. In severe cases, phototherapy or the use of the powerful drugs methotrexate or cyclosporine may be recommended, but these treatment options may carry risks for children.

“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," said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation.
 

Beranek calls the approval “an important development for this patient community, as well as their parents and families" and says it represents a huge leap forward in advancing the treatment of children living with psoriasis.

Study results

In addition to dealing with physical discomfort, kids coping with psoriasis may face psychological distress. Teasing at school can result in low self-esteem and trouble maintaining friendships. For children dealing with these issues, Enbrel’s FDA approval may be good news.
 

Enbrel obtained FDA approval following a successful year-long Phase 3 study. A five-year open-label extension study helped evaluate the drug’s safety and efficacy in children. The results showed that not only was the drug effective, its adverse effects were similar to those seen in previous studies with adults.

Making sure the drug could be prescribed as a safe treatment option for children with chronic plaque psoriasis was a top priority, said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
 

Enbrel’s FDA approval, he says, “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."


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