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
|Contact: Amy Losak|
Takeda Pharmaceuticals North America