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Johnson & Johnson’s experimental drug, ustekinumab appears
to be effective in treating psoriasis, but its long-term use could slightly
increase cancer risks, the U.S. Food and Drug Administration wrote in an
analysis released on Friday, a few days before an advisory panel would discuss
the drug’s efficacy and dosing.
Centocor Inc., a unit of Johnson & Johnson, is seeking
approval for the drug to treat adults with chronic moderate to severe plaque psoriasis.
Psoriasis, a skin disorder that causes scaly red patches,
affects an estimated 7.5 million Americans.
Ustekinumab injections work by blocking an inflammation-causing
protein called tumor necrosis factor (TNF). Animal studies showed suppression of
these proteins raised the chances of developing cancer, the FDA reviewer said.
An advisory panel is scheduled to discuss on Tuesday ustekinumab’s
potential dangers that may arise in people taking the drug without medical
supervision. Also the FDA will ask the panel whether or not to put animal data (highlighting
the cancer risk) on the label of the drug or whether the company should do more
research on the safety issue.
If approved, ustekinumab would compete fierce competition
from other leading injectable drugs like Amgen Inc and Wyeth’s Enbrel and
Abbott Laboratories Inc.’ Humira, as well as Johnson & Johnson’s Remicade, administered
by intravenous infusion.
The FDA is expected to make its decision on whether to
approve ustekinumab for sales in the U.S. in September.
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