FDA Approves Zurampic with Gout Indication

FDA has approved AstraZeneca’s Zurampic (lesinurad) to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI). An agency news release says the drug works by helping the kidney excrete uric acid. It does this, FDA says, by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

Zurampic’s safety and efficacy were evaluated in three clinical trials involving 1,537 participants for up to 12 months. FDA says that participants treated with Zurampic in combination with an XOI experienced reduced serum uric acid levels compared to placebo. The most common adverse reactions during the trials were headache, flu, increased blood creatinine, and gastroesophageal reflux disease.

The drug’s labeling includes a Boxed Warning about the risk for acute renal failure. FDA also is requiring a postmarketing study to further evaluate the drug’s renal and cardiovascular safety.