Pharmacy News Article

RDATE:13022009

The U.S. Food and Drug Administration has approved Uloric (febuxostat) for the management of a painful form of arthritis known as gout.

Uloric works by reducing levels of uric acid, a waste product that is produced during digestion or ordinary metabolism. If uric acid levels in the blood are too high, crystals may form in the big toe, foot, ankle, or knees. Formation of these crystals can cause an attack of sudden burning pain, stiffness and swelling known as gout.

"This new drug offers an additional choice in the management of this painful condition," said John Jenkins, M.D., director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research.

Uloric will be available in both 40-mg and 80-mg oral tablets.

The drug's efficacy was established in three randomized clinical trials involving over 4,000 patients that compared Uloric to an existing drug, allopurionol. In two of the studies, a higher percentage of Uloric patients who took the 80-mg dose were able to lower the amount of uric acid in their blood to a target level of 6.0 mg/dL than were patients who took allopurinol. In a third study, patients who received the 40-mg. dose of Uloric achieved similar results than did patients who took allopurinol.

In clinical trials, the most common adverse reactions in patients treated with Uloric were liver function abnormalities, nausea, joint pain, and rash.

Although a causal relationship was not established, there was also a numerically higher rate of cardiovascular deaths, non-fatal heart attacks and non-fatal strokes in patients treated with Uloric than treated with allopurinol. The number of cardiovascular events was small in the clinical trials and the higher rate seen with Uloric may have occurred by chance.

As a condition of approval, Takeda will be required to conduct a study to further assess the drug's cardiovascular safety.

Patients should be observed for signs and symptoms of heart attack and stroke.

An FDA Arthritis Advisory Committee met to discuss the safety and efficacy of Uloric. While the committee was concerned about the possibility of increased cardiovascular risk with Uloric, they concluded that the numerically higher rate of cardiovascular events may have occurred by chance but recommended that more data be collected after Uloric is approved.

Uloric is manufactured by Takeda Pharmaceuticals North America Inc., Deerfield, Ill.

CONTACT: Karen Riley, US Food and Drug Administration Tel: +1 301 827 6244

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