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.
|Contact: Amy Losak|
Takeda Pharmaceuticals North America