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FDA committee recommends expansion of Enbrel age group


NEW YORK A Food and Drug Administration advisory committee voted 8-5 Friday to recommend approval of the drug Enbrel to treat plaque psoriasis in children and teenagers, though the FDA is not required to follow the committee’s recommendation.

Enbrel is already approved to treat plaque psoriasis in adults, as well as arthritis in adults and children. The FDA had expressed concerns about possible life-threatening side effects in children who had received the drug for treating psoriasis, including infections and cancers.

In May, Enbrel got a black box warning about the risk of serious infections that may lead to hospitalization or death.

Enbrel (etanercept), which is marketed by Amgen and Wyeth, had sales of $2 billion in 2007, according to Wyeth financial data.

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