FDA Concerned About Enbrel For Children

An FDA advisory committee will meet on Wednesday to review a request by Amgen to market Enbrel for moderate to severe forms of psoriasis in children. The med is used to treat rheumatoid arthritis and psoriasis in adults, but is approved only for Juvenile Idiopathic Arthritis in kids. FDA medical reviewers are concerned about life-threatening complications, according to the FDA briefing documents.

The reviewers noted that "plaque psoriasis is not a life-threatening disease in childhood and complications are rare and largely psychosocial." Enbrel, however, is "associated with life-threatening toxicities such as sepsis, anaphylaxis, and significant long-term morbidities such as malignancy, congestive heart failure, and demyelinating disease."

The FDA recently reviewed all post-marketing pediatric cases in its Adverse Event Reporting System showing death in patients receiving Enbrel, and the majority - 8 of 14 cases - occurred in pediatric patients who were treated for JIA. The agency found nine malignancies, including five in the US, reported in children given Enbrel. Three of nine were lymphoma cases in JIA patients.

"Given that the drug usage in the pediatric population is estimated to be fairly small at this time, the numbers and types of post-marketing adverse events reported are concerning," the FDA reviewers wrote. " Many of these events, especially infection-related complications such as sepsis, were life-threatening and resulted in deaths and hospitalizations.

"Long-term potential toxicities such as malignancies and neurologic events are especially worrisome in children with plaque psoriasis who could receive chronic etanercept therapy. Given these considerable risks associated with etanercept, the benefit of this therapy in children with plaque psoriasis would need to be substantial in order to justify its approval and usage in the pediatric plaque psoriasis population."

Regardless of whether the FDA approves the added indication, the medical reviewers recommended the agency strengthen Enbrel labeling to include warning that the med may lead of serious side effects in children that could lead to deaths and hospitalizations. Amgen, by the way, jointly markets Enbrel with Wyeth.

Source: Written By Ed Silverman from Pharmalot