A new drug for gout appears effective in treating the disease, despite potential cardiovascular side effects, the Associated Press cited the U.S. Food and Drug Administration as saying on Friday.
About one-quarter of clinical trial participants who took Krystexxa had a serious adverse effect, versus 12 percent of those who took a non-medicinal placebo. Six deaths were reported among those who took the drug, compared to three deaths among those who didn't. But the FDA "noted that many of them had pre-existing heart conditions," the wire service reported.
The agency has been reviewing the approval application from the drug's maker, Savient Pharmaceuticals, since December, the AP said. On Friday, the agency said the drug seems to relieve gout's symptoms, primarily painful swollen joints. The condition, affecting some 8 million Americans, is caused by the body's buildup of too much uric acid.
On Tuesday, an FDA panel of experts is set to announce whether it will recommend approval of the drug. The full agency isn't bound by the recommendations of its expert panels, but usually follows them. The full agency's decision is expected by the end of next month, the AP said.