FDA Arthritis Drug Advisory Committee Recommends Approval of Febuxostat for Treatment of Hyperuricemia of Gout

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Figure: Food and Drug Administration

At their November 24, 2008 meeting, the FDA Arthritis Drug Advisory Committee heard updated efficacy and safety data for febuxostat for the treatment of gout-associated hyperuricemia.  The committee’s recommendation was carried on a vote of 12 to 0.  Final FDA approval of the drug is pending; however, FDA approval generally follows the recommendations of the advisory committee.

Febuxostat is similar to the most commonly used urate lowering agent, allopurinol, in that it inhibits xanthine oxidase, an important intermediate in the production of uric acid.  However, as a non-purine analogue, its differences from allopurinol may make it more applicable to patients with allopurinol resistant disease, renal insufficiency that limits allopurinol dosing, and hypersensitivity to allopurinol.

Summaries of publications and presentations of clinical trials of febuxostat compared to allopurinol 300 mg per day can be accessed here and here.  If approved, febuxostat would be the first urate lowering therapy introduced to the U.S. market in more than four decades.  This is significant, since gout affects approximately 1 – 2 % of the U.S. population, the incidence of the disease is increasing in both men and women, and outcomes using current treatments tend to be less than optimal.

Jon Giles, MD

About Jon Giles, MD