Zurampic Approved to Treat Gout-Associated Hyperuricemia

AstraZeneca’s lesinurad (Zurampic) has been approved by the FDA to treat high blood uric acid levels associated with gout, when used in combination with a xanthine oxidase inhibitor.

Zurampic works by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

The FDA’s nod for the drug was based on 3 randomized, placebo-controlled studies involving Zurampic and a xanthine oxidase inhibitor. More than 1500 patients were involved in the studies for up to 1 year.

Those who received the intervention treatment saw reduced serum uric acid levels compared with placebo.

“Controlling hyperuricemia is critical to the long-term treatment of gout,” said Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes.”

Adverse effects may include headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

Zurampic also carries a boxed warning about the risk for renal failure, which can happen when it is used in higher-than-approved doses and without a xanthine oxidase inhibitor, the FDA noted.

The FDA has also called for studies to examine the renal and cardiovascular safety of Zurampic.