November 25, 2008 WASHINGTON (AP) -- Government health advisers Monday recommended approval of the first new drug in 40 years for gout, a painful joint disease that mainly strikes middle-aged men.
About 5 million people in the U.S. suffer from gout, a form of arthritis caused by a build-up of uric acid in the blood. Uloric, as the new drug is called, works by reducing levels of uric acid.
In healthy people, uric acid is dissolved in the blood and excreted from the body in urine. But high levels lead to the formation of needle-like crystals that become deposited in the joints, causing intense pain and swelling. Many patients experience their first attack of gout in the big toe. The disease can progress, causing deformities.
Food and Drug Administration medical reviewers were concerned because early trials of Uloric found a higher risk of death and heart problems from the drug. But Takeda Inc., which makes Uloric, commissioned a much larger clinical study that found no difference in heart risks when compared with the currently available drug, allopurinol.
Takeda said its medication works better for patients with kidney problems. "A lot of gout patients suffer from kidney disease," said Dr. Nancy Joseph-Ridge, head of research and development for the company. "This is something of real need. Patients who could not take the other drug will now have treatment."
The FDA arthritis advisory committee voted 12-0 to recommend approval of Uloric for chronic gout. One member abstained. The FDA usually follows the recommendations of its advisers.
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