Zurampic approved for hyperuricemia

The United States Food and Drug Administration (USFDA) approved Zurampic (Lesinurad) as a combined therapy with xanthine oxidase inhibitor (XOI) for treatment of hyperuricemia associated with gout. Zurampic is to be manufactured by AstraZeneca.
 
Zurampic lowers serum uric acid levels by inhibiting the transporter proteins function involved in uric acid renal reabsorption and elimination.
 
Three randomized, placebo-controlled clinical trials were conducted to demonstrate the safety and efficacy of Zurampic. About 1,537 study subjects were involved and the study duration was 12 months. The study participants were treated with Zurampic with an XOI or a placebo. Reduced serum uric levels were observed in the treatment group, compared with the placebo group.
 
Zurampic is to be marketed with Boxed Label Warning about the potential risk of acute renal failure. The risk is higher when Zurampic is administered as a monotherapy and/or taking higher than recommended doses of Zurampic.

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