FDA to Review Expanded Indication for Children's Plaque Psoriasis Drug

The FDA is reviewing Amgen’s supplemental biologics license application for the expanded use of etanercept (Enbrel) to treat pediatric patients with chronic severe plaque psoriasis.

"If approved, Enbrel would be the first systemic drug approved in the United States to treat chronic severe plaque psoriasis in pediatric patients," said Sean Harper, executive vice president of research and development at Amgen, in a press release. "We hope to be able to provide pediatric patients with an important new treatment option where there is a clear unmet medical need."

The FDA decided to review the application based on results from a 1-year phase 3 study, as well as a 5-year extension study. These studies examined the safety and efficacy of Enbrel in pediatric patients with moderate to severe plaque psoriasis.

The FDA has set a prescription drug user fee act target action date of November 5, 2016.

Enbrel was originally approved to treat moderate to severe rheumatoid arthritis. It may also be used to treat other conditions such as ankylosing spondylitis to plaque psoriasis.

The most common adverse effects associated with the drug are redness and swelling at the injection site, upper respiratory infections, and headache.