New Gout Treatment Gets FDA Approval

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

Zurampic inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, Zurampic increases uric acid excretion and thereby lowers serum uric acid. It also inhibits organic anion transporter (OAT) 4, a uric acid transporter involved in diuretic-induced hyperuricemia.

The FDA approval for Zurampic was based on data from 3 randomized, placebo-controlled studies in combination with a XOI that included 1,537 patients for up to 12 months. In the CLEAR1 and CLEAR2 studies, treatment with Zurampic in combination with a XOI met the primary endpoint with about twice as many patients achieving the serum uric acid goal of <6mg/dL by Month 6 vs. those treated with allopurinol alone. In the CRYSTAL study, Zurampic in combination with febuxostat showed greater serum uric acid lowering to the tophaceous gout target of <5mg/dL vs. febuxostat alone at all months except at the time of the primary endpoint.

Zurampic is approved with a Boxed Warning regarding an increased risk for acute renal failure when used without a XOI and when used in higher doses than approved. The Company is required to conduct a postmarketing study to further assess the renal and cardiovascular safety of taking Zurampic.

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