WASHINGTON (AP) - The Food and Drug Administration has approved the first new treatment for gout in more than 40 years, a company said Saturday.
Takeda Inc. said Uloric, a once-daily drug, was approved by the FDA on Friday to fight 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 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.
"We are pleased to offer a new treatment option, the first in 40 years, to the more than five million Americans who have hyperuricemia associated with gout, fulfilling an unmet need," said Alan MacKenzie, president and CEO, Takeda Pharmaceuticals North America, Inc., which is based in Deerfield, Ill.
The FDA arthritis advisory committee voted 12-0 to recommend approval of Uloric for chronic gout in November.
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