FDA backs wider use of Amgen drug for kids
SILVER SPRING, Maryland (Reuters) - U.S. health officials should approve wider use of Amgen Inc's drug Enbrel to treat psoriasis in children, a Food and Drug Administration advisory panel said on Wednesday.
But the panel was divided over whether to fully support Amgen's request to market the drug for youth with moderate to severe forms of the skin disease, saying it should be reserved for only the worst cases given the drug's potentially life-threatening side effects, such as cancer.
"This is a serious drug for a serious condition," said panelist Lynn Drake, a dermatologist at Massachusetts General Hospital in Boston.
If approved, Enbrel would be the first U.S.-approved treatment for children with the disease, which can cause scaly, rash-like bumps. The drug, co-marketed by Wyeth, is already approved to treat arthritis in adults and children.
The agency will weigh the panel's advice before making a final decision but usually follows panel recommendations.
Officials for Amgen said they did not expect the drug to be used widely if the new indication were approved, with just 1,000 young psoriasis patients eligible a year.
"We're guessing uptick will be slow," Paul Eisenberg, Amgen's senior vice president for global regulatory affairs and safety, told the panel.
Shares of Amgen declined 15 cents at $44.24 in afternoon trade on Nasdaq while Wyeth shares rose 40 cents to $45.56 on the New York Stock Exchange.
(Reporting by Susan Heavey; Editing by Richard Chang and Gerald E. McCormick)
