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4 Jan 2016

USFDA approval of Zurampic

The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.

Zurampic works by helping the kidney excrete uric acid. It does this by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

The safety and efficacy for Zurampic were evaluated in three randomized, placebo-controlled studies in combination with a XOI involving 1,537 participants for up to 12 months. Participants treated with Zurampic in combination with a XOI experienced reduced serum uric acid levels compared to placebo.

The most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

Zurampic has a boxed warning that provides important safety information for health care professionals, including the risk for acute kidney (renal) failure, which is more common when used without an XOI and with higher than approved doses of Zurampic.

The FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of Zurampic.

Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.

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