ULORIC® (TMX-67, febuxostat) Receives FDA Approval for the Chronic Management of Hyperuricemia in Patients with Gout
Tokyo and Osaka, Japan, February 14, 2009 - Teijin Pharma Limited (Head office: Chiyoda-ku, Tokyo; President: Osamu Nishikawa, hereafter "Teijin Pharma") and Takeda Pharmaceutical Company Limited (Head office: Chuo-ku, Osaka; President: Yasuchika Hasegawa, hereafter "Takeda") announced today that on February 13, 2009, Teijin Pharma's U.S. licensee for febuxostat and Takeda's wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., (Head office: Deerfield, Illinois) received FDA marketing approval for ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout. Takeda Pharmaceuticals North America is the sole developer and marketer of the product, ULORIC in the U.S.
Febuxostat was discovered by Teijin Pharma after intensive research, and is an oral, once-daily, novel highly potent non-purine selective inhibitor of xanthine oxidase[*], having a structure completely different from that of the currently available xanthine oxidase inhibitor, which was developed over 40 years ago. Febuxostat lowers the level of uric acid in the blood of hyperuricemic patients with gout, with clinical data supporting its safety and efficacy. In addition, febuxostat's safety profile does not require dose adjustment for patients with mild-to-moderate renal or hepatic impairment.
[*] An enzyme directly related to the production of uric acid
"This FDA approval granted to Takeda Pharmaceuticals North America, along with the EMEA (European Medicines Agency) approval given last year to Ipsen, our licensee for febuxostat in Europe, marks a significant milestone for our global business," said Osamu Nishikawa, President of Teijin Pharma. "As to Japan and other areas including Asia, we are proceeding with our plans to develop febuxostat by ourselves as well as by collaborating with other companies. We will continue to strengthen our global operations by expanding areas where febuxostat is available and increase the presence of the product to be widely used by patients worldwide."
"The approval of ULORIC offers patients and healthcare providers in the U.S., for the first time in 40 years, a novel treatment option for patients who have hyperuricemia with gout, where there are still unmet clinical needs," said Yasuchika Hasegawa, President of Takeda. "Together with recently approved KAPIDEXTM, ULORIC® will significantly enhance Takeda's product line-up in the U.S. We expect these products will allow us to further increase our presence in the U.S. Primary Care Physician (PCP) market".
ULORIC® approved by the FDA
Product name : ULORIC®
Generic name : febuxostat
Pharmaceutical Forms and Strength : Tablets 40 mg and 80 mg
Authorized Indications : Chronic management of hyperuricemia in patients with gout. Not recommended for the treatment of asymptomatic hyperuricemia.
Dosage and Administration : 40 mg or 80 mg once daily.