The first new gout treatment in four decades has been approved by the U.S. Food and Drug Administration after more than four years of review due to concerns about dosing and a potential increased risk of heart attack and stroke.
The FDA approved febuxostat (brand name Uloric) to control excess uric acid in the blood that can build up in joints or soft tissues, Bloomberg news reported. About six million Americans have gout.
Japanese drug maker Takeda Pharmaceuticals Co. initially sought approval for 80-milligram and 120-milligram oral doses of the drug. However, regulators were concerned about a higher number of cardiovascular side effects in patients taking the drug and requested a new study using only 80-milligram and 40-milligram doses.
Both lower doses proved effective and weren't linked to a higher rate of heart attack or stroke in patients taking the drug, Bloomberg reported.
Febuxostat was approved by European regulators last May.