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Febuxostat wins approval for gout.

For the first time since 1964, the Food and Drug Administration has approved a drug for treating patients with gout.

The FDA approved febuxostat for the long-term management of chronic hyperuricemia in patients with gout, based on data from three clinical trials in mostly white, male patients who had gout and hyperuricemia (baseline serum uric acid level of at least 8 mg/dL). The 80-mg dose of febuxostat was more effective than allopurinol--and the 40-mg dose of febuxostat was as effective as allopurinol--in lowering and maintaining serum uric acid below 6.0 mg/dL, the treatment goal.

Febuxostat, which will be marketed as Uloric by Takeda Pharmaceuticals North America Inc., will be available in 40-mg and 80-mg tablets. The recommended starting dosage is 40 mg once daily, increasing to 80 mg once daily if, after 2 weeks, a patient does not achieve a serum uric acid level less than 6 mg/dL, according to the prescribing information.

Approval of febuxostat was delayed for several years. After reviewing two phase III trials submitted in 2004, the FDA asked the company to conduct another study. The initial trials showed that cardiovascular thromboembolic events were more frequent among patients treated with febuxostat 80 mg/day and 120 mg/day, compared with those on allopurinol or placebo, although the number of events was small. In the third trial of 2,269 predominantly male patients with hyperuricemia, the rates of cardiovas-cular events were similar among men on 40 mg/day or 80 mg/day of febuxostat and those on allopurinol (200-300 mg/day), according to Takeda, which presented those data at a meeting of the FDA's Arthritis Drugs Advisory Committee last November.

At the meeting, the panel voted 12-0, with 1 abstention, to recommend approval of febuxostat for treating chronic gout, but also recommended that studies further evaluating the drug's cardiovascular safety be conducted after approval. The panel agreed that available data on febuxostat at doses of 40 mg/day and 80 mg/day provided evidence that it would be useful for patients with gout, and would fill an unmet need for treating hyperuricemia in patients who are intolerant to or allergic to allopurinol, as well as in those patients with renal impairment who have to take a lower, less-effective dose of allopurinol.

The higher rate of cardiovascular thromboembolic events in patients who were treated with febuxostat is mentioned in the warnings and precautions section of the drug's label, which states that "a causal relationship with Uloric has not been established." The label calls for patients on the drug to be monitored for signs and symptoms of MI and stroke.

Like allopurinol, febuxostat inhibits xanthine oxidase, but is selective and does not inhibit other enzymes.

"The benefit for this drug is clearly for those who can't tolerate allopurinol or in whom [allopurinol] has been ineffective," Dr. Robert L. Wortmann, professor of medicine at the Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. Dr. Wortmann has been a consultant to Takeda and to Tap Pharmaceutical Products Inc., which was acquired by Takeda; he was involved in the design of the clinical trials, but was not an investigator.
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Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Geographic Code:1USA
Date:Apr 1, 2009
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