FDA Okays New Treatment for Gout

FDA Okays New Treatment for Gout-Related Hyperuricemia

By Todd Neale, Staff Writer, MedPage Today
Published: February 16, 2009

DEERFIELD, Ill., Feb. 16 -- The FDA has approved febuxostat (Uloric) for chronic management of hyperuricemia in patients with gout, the drugmaker announced.
The drug -- to be available in once-daily 40 and 80 mg tablets -- is the first new treatment option for the condition in more than 40 years, according to Takeda Pharmaceuticals North America here.

It inhibits xanthine oxidase, the enzyme responsible for uric acid production.

In several clinical trials, febuxostat was more effective than both placebo and allopurinol -- the other approved treatment for hyperuricemia in patients with gout -- in lowering serum uric acid levels. (See: Febuxostat Trumps Allopurinol for Reducing Gout Uricemia and Febuxostat Lowers Urate More Than Aloprim in Gout)

In the six-month pivotal phase III trial CONFIRMS, the percentage of patients who achieved levels below 6 mg/dL was significantly higher with the 80-mg dose (67%) than with the 40-mg dose (45%) or allopurinol (42%) (P<0.001 for both).

In the clinical trials, the most commonly reported adverse reactions were liver function abnormalities, nausea, arthralgia, and rash.

There was also a higher rate of cardiovascular thromboembolic events in patients who took febuxostat than in those who received allopurinol (0.74 versus 0.60 per 100 patient-years), although a causal relationship has not been established, Takeda said.

Febuxostat is contraindicated in patients who are taking azathioprine, mercaptopurine, or theophylline because of the risk of increased plasma concentrations of these drugs resulting in severe toxicity, according to the prescribing information.