FDA Approves Zurampic for Patients With Gout

Ricki Lewis

Disclosures

December 22, 2015

The US Food and Drug Administration (FDA) has approved lesinurad (Zurampic, AstraZeneca) 200 mg once daily to treat gout-associated hyperuricemia, in combination with a xanthine oxidase inhibitor (XOI).

Lesinurad works by inhibiting the urate transporter URAT1, which is responsible for the majority of the renal reabsorption of uric acid. The end result is a dual mechanism of action that increases excretion and decreases production of uric acid.

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

Gout presents as sudden onset of severe pain in and swelling of a joint, in many cases in the big toe. It affects 1.6 million people in the United States, 85% of whom are men. Only some people with hyperuricemia develop gout.

Three randomized, placebo-controlled studies evaluated the safety and efficacy of lesinurad with an XOI in 1537 participants for up to 12 months. The treated patients had reduced serum uric acid levels compared with placebo. Adverse reactions included headache, increased blood creatinine, and gastroesophageal reflux disease. Use without an XOI or in too high a dose increased risk for acute renal failure.

An FDA advisory board recommended approval in October, but some members of the committee expressed concern about the drug's safety profile. A 400-mg dose of the drug was associated with an increase in the incidence of adverse events, serious adverse events, serious and nonserious renal adverse events, major adverse cardiovascular events, and death compared with placebo.

The approved dose of 200 mg was associated with a lower incidence of serious adverse events and was considered safe.

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