FDA Experts Recommend Gout Drug's Approval
An expert panel advising the U.S. Food and Drug Administration voted 14-1 on Tuesday to recommend that the full agency approve the Savient Pharmaceuticals drug Krystexxa (pegloticase), Dow Jones reported.
Last week, the FDA released documents saying that although the drug appeared to relieve the painful, swollen joints that characterize gout, it was concerned about the higher rate of cardiovascular side effects that surfaced during clinical testing.
About 24 percent of clinical trial participants who took Krystexxa had a serious adverse effect, compared with 12 percent of those who took a non-medicinal placebo. Six deaths were reported among those who took the drug, versus three deaths among those who didn't. But the FDA "noted that many of them had pre-existing heart conditions," the Associated Press reported.
The FDA has been reviewing the approval application from the drug's maker since December, the AP said.
Gout, which affects an estimated 8 million Americans, is caused by the buildup of too much uric acid in the body.
The full agency is not bound by the recommendations of its expert panels but usually follows them. The FDA's decision is expected by the end of July.
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July 9, 2009 - 7:20pmThis Comment