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FDA panel backs proposed J&J psoriasis drug
Jun 19, 08 Clinical Updates FDA ApprovalsJohnson & Johnson’s experimental drug ustekinumab should be approved for treating adults with moderate or severe psoriasis, a U.S. advisory panel unanimously ruled on Tuesday.
Panel members said the drug’s potential to relieve symptoms of the skin disease outweighed concerns that long-term use might increase the risk of cancer.
“It’s quite striking how well it works compared to other things that we have available,” said panel chairman Michael Bigby, associate professor of dermatology at Beth Israel Deaconess Medical Center in Boston.
The manufacturer said the cancer risk was theoretical and it would further study the issue after approval.
The Food and Drug Administration will consider the advice from the panel of outside experts before making a final decision, which is expected by September. The FDA usually follows panel recommendations.
Sales of the drug could reach $500 million by 2011, JP Morgan analyst Michael Weinstein has estimated.
SILVER SPRING, Maryland (Reuters)
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