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FDA advisory committee votes yes to etanercept for children


Senior Director of Advocacy and External Affairs, Sheila Rittenberg, Kelsey Larson, and Kelsey's mother, Leslie Watkins, testified the FDA hearing on etanercept in the pediatric population.

On June 18, the Dermatologic and Ophthalmic Drugs Advisory Committee recommended the approval of etanercept (brand name, Enbrel) to treat moderate to severe plaque psoriasis in children ages 4-17. The vote was 8-5.

During the advisory committee hearing, National Psoriasis Foundation staff member, Sheila Rittenberg, and volunteer, Kelsey Larson, testified on behalf of the National Psoriasis Foundation. Both emphasized the importance of approving etanercept to treat psoriasis in children.

"I was four when I developed psoriasis," testified Senior Director of Advocacy and External Affairs Sheila Rittenberg. "None of the treatments really worked ... but there were no other choices. And if you now fast-forward some fifty years and look around, it's not much different today for children with psoriasis."

Psoriasis Foundation Senior Director of Advocacy and External Affairs testifies before Food and Drug Administration (FDA) re: use of etanercept in pediatric population  June 18, 2008 (94k PDF)

"I began seeing a new dermatologist who worked ... to get Enbrel approved for me," said Kelsey Larson, a 16-year-old from Minnesota. "Going to my junior prom this year was awesome—but without Enbrel, I would not have been so confident, nor would I have been as physically comfortable."

Psoriasis Foundation member Kelsey Larson testifies before Food and Drug Administration (FDA) re: use of etanercept in pediatric population  June 18, 2008 (79k PDF)

"I commend the advisory committee for giving serious consideration to etanercept. We look forward to the FDA's final decision," says National Psoriasis Foundation Director of Research Bruce Bebo, Ph.D.


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