First new treatment option in more than 40 years, marking second FDA approval for Takeda within one month
Deerfield, Ill., and Osaka, Japan, February 13, 2009 – Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the United States Food and Drug Administration (FDA) has approved ULORIC® (febuxostat) 40 mg and 80 mg for the chronic management of hyperuricemia in patients with gout. This once-daily, oral medication is the first new treatment option in more than 40 years for the more than five million patients who have hyperuricemia associated with gout. ULORIC was discovered by Teijin Pharma Limited (Teijin Pharma) of Tokyo and licensed to Takeda for the U.S. market.
“The approval of ULORIC offers clinicians and their patients who have hyperuricemia associated with gout a new treatment option that helps prevent uric acid production," said Nancy Joseph-Ridge, M.D., president, Takeda Global Research & Development Center, Inc., U.S. "In the years that we've dedicated to studying patients who have gout, I know that many patients go to their doctor during a flare not understanding that gout is a chronic disease that needs to be managed on a long-term, daily basis."
Experts recognize that a goal in the treatment of chronic gout is the reduction and maintenance of serum uric acid levels of less than 6 mg/dL. ULORIC, a xanthine oxidase inhibitor, effectively lowers levels of serum uric acid in patients with hyperuricemia associated with gout. It 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 the primary end point of serum uric acid 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® (febuxostat)
ULORIC works by blocking the enzyme xanthine oxidase. Xanthine oxidase is responsible for the breakdown of the purine base, hypoxanthine, to xanthine, and then to uric acid. By blocking this enzyme, ULORIC helps prevent uric acid production, thereby lowering elevated levels of serum uric acid.
Important Safety and Other Information
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.
Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
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 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, rheumatology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.
Takeda Pharmaceutical Company Limited
Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.