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FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
Date:2/13/2009

less than 6.0 mg/dL at the final visit (both p<0.001).

ULORIC has an established safety profile with no dose adjustments required in patients with mild-to-moderate renal or hepatic impairment. The most commonly reported adverse reactions were liver function abnormalities, nausea, joint pain and rash.

"We are pleased to offer a new treatment option, the first in 40 years, to the more than five million Americans who have hyperuricemia associated with gout, fulfilling an unmet need," said Alan MacKenzie, president and CEO, Takeda Pharmaceuticals North America, Inc. "At Takeda, we are deeply committed to developing strong clinical programs and bringing to market innovative therapies, like ULORIC, for patients. This approval is a significant milestone for Takeda, as it marks our second approval within a month."

About Gout and Hyperuricemia

Uric acid is an end-product created when the body breaks down substances called purines. Hyperuricemia occurs when this process results in elevated uric acid levels, either through overproduction or underexcretion of uric acid or a combination of the two. Hyperuricemia is a precursor to gout; the higher a person's urate level, the greater the risk for developing gout.

Gout is the most common inflammatory arthritis in men over age 40. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition characterized by attacks, or "flares," marked by intense pain, redness, swelling and heat in the affected joint.

These symptoms are the result of an acute inflammatory response to the presence of crystallized uric acid in the joint(s). As the disease progresses, gout symptoms may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi.

About ULORIC (febuxo
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SOURCE Takeda Pharmaceutical Company Limited
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