WASHINGTON (AP) — A panel of arthritis experts is scheduled to vote Tuesday on whether a gout drug made by Savient Pharmaceuticals should be approved, despite a high number of heart-related side effects seen during testing. The FDA said in documents posted last week that the drug Krystexxa appears effective at treating pain and swelling associated with gout, a condition caused by a buildup of uric acid in the body. But the FDA has asked an outside panel of medical specialists to weigh in on negative side effects reported with the drug, including heart problems and allergic reactions. Overall, about 24 percent of patients taking Krystexxa suffered a serious side effect, compared with 12 percent of patients taking a placebo pill, the FDA said. There were six deaths among patients taking the drug compared with three among patients taking placebo, though the FDA noted many of them had pre-existing heart conditions. The FDA plans to ask its experts whether additional safety studies of the drug are needed. The agency is not required to follow the group’s advice, though it usually does. A final decision on Savient’s drug is expected by the end of July. Despite the safety concerns outlined last week, Wall Street analysts expect a positive outcome for the company on Tuesday. “The briefing document was milder than we expected, and seems to correspond to our hypothesis that the benefit to Krystexxa outweighs the risk,” Roth Capital Partners analyst Andrew Vaino wrote in a research note Friday. Savient Pharmaceuticals is based in East Brunswick, N.J., and specializes in niche drugs for under-treated diseases.
