WASHINGTON (AP) - Federal regulators said Monday an Amgen drug used to treat
a severe skin disorder was associated with sometimes lethal infections when used
in children.
Amgen has asked the Food and Drug Administration to approve its drug Enbrel
to treat children with psoriasis, a painful disease that causes red scales to
grow on the skin. The drug is already approved to treat psoriasis and rheumatoid
arthritis in adults and juvenile arthritis in children.
But FDA scientists expressed concern about broadening the drug's approval
Monday, citing reports of dangerous side effects in children who have already
taken the drug. Based on agency records, the FDA said the drug has been linked
to infections that sometimes led to hospitalization and death. A small number of
children taking the drug also developed cancers, including lymphoma.
Earlier this month, the FDA announced it was investigating whether Enbrel
and similar drugs -- including Johnson & Johnson's Remicade and Abbott
Laboratories' Humira -- increase the risk of cancer in children.
Given such risks, "the benefit of this therapy in children with plaque
psoriasis would need to be substantial in order to justify approval," FDA said
in documents posted online Monday.
On Wednesday a panel of outside experts will vote on whether Enbrel should
be cleared for the new use. FDA is not required to follow the panel's advice,
though it usually does.
Regardless of whether the drug is approved to treat psoriasis, FDA's
reviewers recommended adding stronger warnings that Enbrel can lead to dangerous
infections when used in children.
Shares of Amgen Inc. fell 2 cents to $43.95 in morning trading.
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