Amgen’s Enbrel in kids ‘concerning,’ FDA staff says

U.S. drug regulators are concerned about life-threatening complications in children taking Amgen Inc’s drug Enbrel for psoriasis and other conditions, according to documents released on Monday.

Amgen, which markets the injectable drug with Wyeth, is seeking approval from the U.S. Food and Drug Administration to expand sales to children with moderate to severe forms of the skin condition. The drug is already approved as an arthritis treatment in adults and children.

Regardless of whether the regulators approve the new use, FDA staff reviewers recommended the agency strengthen the drug’s label to include reports of serious side effects in children that could lead to deaths or hospitalizations.

The FDA documents were released ahead of a public meeting scheduled on Wednesday to discuss whether to allow marketing of the drug for children.

FDA safety reviewers looked at 949 reports of serious complications in children ages 4 to 17 taking Enbrel, or etanercept, for psoriasis as well as arthritis.

Among them, 61 reports were for psoriasis patients, according to the documents. No deaths were reported, but five patients were hospitalized.

Overall, the FDA found 14 deaths and 76 other life-threatening cases. Complications included serious sepsis and other infections as well as seizures and anemia.

“Given that the drug usage in pediatric population is estimated to be fairly small at this time, the numbers and types of post-marketing adverse events reported are concerning,” the reviewers wrote.

While Enbrel is not cleared to treat psoriasis in children, doctors are allowed to prescribe it as they see fit. FDA-approval for the expanded use would allow the companies to lawfully market the product for such patients.

In morning trade, shares of Amgen were off 12 cents at $43.79 on the Nasdaq, while shares of Wyeth were off 74 cents, or 1.7 percent, at $42.68 on the New York Stock Exchange.