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Uloric

Generic name: febuxostat
Treatment for: Gout

Update: Uloric (febuxostat) Now FDA Approved - February 13, 2009

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

DEERFIELD, Ill., and OSAKA, Japan, November 24, 2008 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout. The vote was 12 to zero in favor of approval, with one panel member abstaining. The vote followed presentations by Takeda Global Research & Development Center, Inc., the FDA, and invited guest speakers. If approved in the United States by the FDA, febuxostat will be the first new treatment for the management of hyperuricemia associated with gout in more than 40 years.

The FDA will review the current new drug application for febuxostat and make its approval decision. The FDA's decision may or may not follow the Committee's recommendation.

"Today's vote by the Arthritis Advisory Committee, recommending approval of febuxostat for the treatment of hyperuricemia in patients with gout, is a positive step in bringing this new treatment to market," said Nancy Joseph-Ridge, MD, president, Takeda Global Research & Development, Inc., U.S. "Takeda is committed to developing innovative therapies that fulfill unmet treatment needs, and we believe febuxostat will represent an important new option for patients who suffer the debilitating effects of gout. In the coming months, we will work with the FDA to complete their review, including the design of post-marketing studies."

Febuxostat is a potent non-purine, selective inhibitor of xanthine oxidase, which was studied for its ability to lower levels of serum uric acid in patients with hyperuricemia associated with gout. Hyperuricemia, elevated uric acid levels in the body, is associated with gout, a painful type of arthritis. In clinical trials, febuxostat 40 mg and 80 mg were shown to be effective treatments for the management of hyperuricemia associated with gout. Both doses were well tolerated and required no dose adjustments in patients with renal impairment. The most commonly reported adverse events were upper respiratory tract infections, musculoskeletal and connective tissue signs and symptoms, and diarrhea.

Uric acid is an end-product created when the body breaks down naturally occurring 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, these attacks may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi, that can eventually lead to complications including pain, soft tissue damage and deformity, as well as joint destruction and nerve compression syndromes such as carpal tunnel syndrome.

Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan, and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, oncology, gastroenterology, neurology, rheumatology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

CONTACT: Matt Kuhn, Takeda Pharmaceuticals North America, Inc.,+1-224-554-5609, or cell, +1-847-687-6205, ; or Seizo Masuda,Takeda Pharmaceutical Company Limited, ; or AmyLosak, Ketchum, +1-646-935-3917, cell, +1-917-865-6688, mkuhn@tpna.com Masuda_Seizo@takeda.co.jp amy.losak@ketchum.com

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Posted: November 2008

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