Arthritis Advisory Committee Recommends FDA Approval Of Febuxostat For The Treatment Of Hyperuricemia In Patients With Gout

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.



About Gout and Uric Acid



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 Pharmaceutical Company Limited



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. Additional information about Takeda is available through
its corporate website, takeda.



Takeda Pharmaceuticals North America, Inc. and Takeda Global Research
& Development Center, Inc.



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. To learn more about these Takeda companies,
visit tpna.

Takeda Pharmaceuticals