Of 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.
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.
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.
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.
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."