March 13, 2009
Takeda Pharmaceuticals North America, Inc.
First new treatment option in 40 years for chronic management of condition
Deerfield, Ill., March 12, 2009 – Takeda Pharmaceuticals North America, Inc. announced today that ULORIC® (febuxostat) is now available by prescription in pharmacies across the United States for the chronic management of hyperuricemia in patients with gout. Gout is a chronic condition that affects more than five million Americans. This once-daily oral medication, available in 40-mg and 80-mg tablets, is the first new treatment option for hyperuricemia in patients with gout in more than 40 years. ULORIC was discovered by Teijin Pharma Limited (Teijin Pharma) of Tokyo and licensed to Takeda for the U.S. market.
Gout occurs when too much uric acid builds up in the blood, a condition know as hyperuricemia. Excess uric acid can form needle-like crystals that collect in the joints, most commonly the big toe. Experts recognize that a goal in the treatment of gout is the reduction and maintenance of serum uric acid levels of less than 6.0 mg/dL. Daily treatment with ULORIC may help reduce and maintain uric acid levels by blocking the enzyme that produces it, xanthine oxidase.
ULORIC was studied and evaluated in multiple clinical trials involving more than 4,000 subjects, in some for up to five years. The largest, pivotal, phase 3 clinical trial, CONFIRMS, demonstrated that ULORIC 80 mg was superior to ULORIC 40 mg and allopurinol 300/200 mg (67 percent, 45 percent and 42 percent, respectively) at achieving serum uric acid levels of less than 6.0 mg/dL at the final visit (both p<0.001).
ULORIC has an established safety profile with no dose adjustments in patients with mild-to-moderate renal impairment, a condition often associated with patients who have hyperuricemia and gout. In a study that included an assessment of this special population of patients, a higher proportion of patients achieved a serum uric acid level less than 6.0 mg/dL at the final visit with ULORIC 40 mg (50 percent) and ULORIC 80 mg (72 percent) versus allopurinol 300/200 mg (42 percent) (p<0.021 and p<0.001, respectively).
ULORIC is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.
ULORIC is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline. An increase in gout flares is frequently observed during initiation of anti-hyperuricemic
agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months. A higher rate of cardiovascular thromboembolic events was observed in patients treated with ULORIC (0.74 per 100 patient-years) than allopurinol (0.60 per 100 patient-years) in clinical trials. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke. Transaminase elevations have been observed in ULORIC-treated patients. No dose-effect relationship for these transaminase elevations was noted. Monitor liver function tests periodically. Adverse reactions occurring in at least 1 percent of ULORIC- treated patients, and, at least 0.5 percent greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash.
Please see complete Prescribing Information and visit the ULORIC Web site at www.uloric.com.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, oncology, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
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