FDA panel supports Enbrel for child psoriasis

June 20, 2008

A Food and Drug Administration (FDA) advisory panel has come out in favor of a request by Amgen Inc. to broaden the use of Enbrel to include moderate to severe child psoriasis.

A Food and Drug Administration (FDA) advisory panel has come out in favor of a request by Amgen Inc. to broaden the use of Enbrel to include moderate to severe child psoriasis.

If the panel's recommendation is approved by the FDA, Enbrel (etanercept) will be the first approved treatment for pediatric psoriasis in the US.

However, according to Reuters, the panel expressed concern regarding the potential for life-threatening adverse events that have been linked to the drug. Malignancies have been reported in pediatric patients with juvenile idiopathic arthritis and other conditions treated with Enbrel.

Enbrel was first approved by the FDA in 1998 for the treatment of adult rheumatoid arthritis, and is currently approved for the treatment of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and adult plaque psoriasis.