The US Food and Drug Administration (FDA) has given approval to lesinurad (Zurampic, AstraZeneca). As per the approval, 200 mg of the drug has to be taken once daily for the treatment of gout-associated hyperuricemia, combined with a xanthine oxidase inhibitor (XOI).

In a news release announcing the approval, Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said, “Lesinurad increases uric acid’s excretion and reduces its production. 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”.

In many cases, gout leads to sudden onset of severe joint pain and swelling in the big toe. In the United States, it affects 1.6 million people, with 85% men. Just a few people with hyperuricemia suffer from gout.

For nearly 12 months, 3 randomized, placebo-controlled studies assessed the efficacy and safety of lesinurad with an XOI. The studies included 1537 participants. The patients, who have undergone treatment, reported reduced serum uric acid levels in comparison to placebo. There were some severe reactions, including increased blood creatinine, headache and gastroesophageal reflux disease. Acute renal failure risk increased while using without an XOI or in quite high a dose.

In October, approval was recommended by an FDA advisory board, but a few members of the committee expressed concern regarding the safety profile of the drug. A 400-mg dose of the drug was linked to a rise in the incidence of severe events, serious and nonserious renal adverse events, serious adverse events, major adverse cardiovascular events, and death as compared to placebo.

The 200 mg approved dose was linked to a lower occurrence of serious adverse events and has been considered risk free.