(Reuters) - U.S. health regulators on Tuesday approved AztraZeneca's AZN.L drug Zurampic to treat a condition associated with gout to be used in combination with another type of drug that reduces production of uric acid in the body.
Zurampic, known chemically as lesinurad, works by helping the kidneys to excrete uric acid. Gout is a painful form of arthritis caused by the buildup of too much uric acid in the body.
“Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes,” Badrul Chowdhury, head of the Food and Drug Administration’s pulmonary, allergy and rheumatology products division, said in a statement.
As a condition of the approval, the FDA said it will require AstraZeneca to conduct a study to further assess the kidney and heart safety of the medicine.
The drug’s label will include a warning alerting health-care professionals to the risk of kidney failure with certain unapproved uses, such as with higher-than-approved doses of Zurampic, the agency said.
Reporting by Bill Berkrot; Editing by Alan Crosby
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