Takeda's Uloric febuxostat approved for hyperuricemia in gout
Teijin Pharma Limited and Takeda Pharmaceutical Company Limited announced that on February 13, 2009, Takeda Pharmaceuticals North America, Inc., received FDA marketing approval for ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout.
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.
"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".
(Editor compiled and published Takeda's Uloric febuxostat approved for hyperuricemia in gout at HealthNewsTrack on February 14, 2009 sourced from Takeda Pharmaceutical Company Limited - http://www.takeda.com/)
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ULORIC (TMX-67, febuxostat) Receives FDA Approval for the Chronic Management of Hyperuricemia in Patients with Gout
ULORIC (TMX-67, febuxostat) Receives FDA Approval for the Chronic Management of Hyperuricemia in Patients with Gout
What is Gout?
About Gout -- Gout is a form of acute arthritis that causes severe pain and swelling in the joints. It most commonly affects the big toe, but may also affect the heel, ankle, hand, wrist, or elbow. Gout usually comes on suddenly, goes away after 5–10 days, and can keep recurring. Gout is different from other forms of arthritis because it occurs when there are high levels of uric acid circulating in the blood, which can cause urate crystals to settle in the tissues of the joints.
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The information provided on Health Newstrack is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician. We comply with the HONcode principles for trustworthy health information, and Health News Track is hon code accredited, verify here.
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