FDA Approves AstraZeneca’s Drug to Treat Hyperuricemia Associated With Gout

Zurampic (lesinurad), a drug to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, has been approved by the US Food and Drug Administration to be used in combination with a xanthine oxidase inhibitor (XOI).The drug is being manufactured by the London-based pharmaceutical company, AstraZeneca. It conducted three clinical trials to evaluate the safety and efficacy of the drug against gout. The randomized clinical trials were carried out in 1,537 participants for 12 months. Participants treated with Zurampic in combination with an XOI experienced reduced serum uric acid levels compared to placebo.

"Controlling hyperuricemia is critical to the long-term treatment of gout. 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.

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.

FDA has approved the drug with a box warning as it has a risk of acute kidney (renal) failure, which is more common when used without an XOI and with higher than approved doses of Zurampic.

Source-Medindia