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Lesinurad (Zurampic) has been approved to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor, the Food and Drug Administration announced on Dec. 22.
Lesinurad promotes uric acid excretion by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.
“Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes,” said Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The drug’s safety and efficacy were evaluated in 1,537 participants in three randomized, placebo-controlled studies of its use in combination with a xanthine oxidase inhibitor. Participants treated for up to 12 months with lesinurad experienced reduced serum uric acid levels, compared with participants given placebo.
The most common adverse reactions in the clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease. Lesinurad has a boxed warning that provides important safety information, including the risk for acute renal failure, which is more common when lesinurad is used without a xanthine oxidase inhibitor and with higher-than-approved doses.
The FDA also said in its statement that the agency is requiring a postmarketing study to further evaluate the renal and cardiovascular safety of lesinurad.
Zurampic is manufactured by AstraZeneca Pharmaceuticals.
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