TAP Submits New Drug Application for Febuxostat for Hyperuricemia in Chronic Gout

Main Category: Gout
Article Date: 17 Dec 2004 - 10:00 PDT

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OSAKA, JAPAN --- Takeda Pharmaceutical Company Limited ("Takeda") announced today that TAP Pharmaceutical Products Inc ("TAP"), its 50-50 joint venture with Abbott Laboratories, submitted a New Drug Application ("NDA") on December 14 with the US Food and Drug Administration for febuxostat 80mg and 120mg for the management of hyperuricemia in patients with chronic gout.

Febuxostat, an oral, once-daily medication, is a novel non-purine, selective inhibitor of xanthine oxidase (NP-SIXO), studied for its effects on lowering levels of serum uric acid (sUA) in patients with gout. TAP licensed febuxostat from Teijin Pharma Limited, based in Tokyo, Japan.

Gout is a chronic condition characterized by attacks, or "flares," marked by intense pain, redness, inflammation, and warmth in the affected joint. The most commonly used treatment in chronic gout is, allopurinol, which has been on the market almost 40 years in the United States.

"We're pleased to be filing an NDA for a compound that could present these patients with a new option," said Alan MacKenzie, president of TAP. "Additionally, this filing represents an important milestone toward our commitment to rheumatology."

"In addition to treating acute attacks of arthritis, the management of chronic gout includes control of the serum urate level. In the clinical studies, more patients taking febuxostat than allopurinol achieved the target level of less than 6.0 mg/dL," said Michael A. Becker, M.D., professor of medicine, University of Chicago.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry's leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
http://www.takeda.co.jp/english/press/04121601.htm