FDA Approves ULORIC(R) (febuxostat) For The Chronic Management Of Hyperuricemia In Patients With Gout

February 16, 2009 at 11:00 am Leave a comment


Takeda Pharmaceutical Company Limited and its wholly-owned
subsidiary, Takeda Pharmaceuticals North America, Inc., announced
today that the United States Food and Drug Administration (FDA) has
approved ULORIC(R) (febuxostat) 40 mg and 80 mg for the chronic
management of hyperuricemia in patients with gout. This once-daily,
oral medication is the first new treatment option in more than 40
years for the more than five million patients who have hyperuricemia
associated with gout. ULORIC was discovered by Teijin Pharma Limited
(Teijin Pharma) of Tokyo and licensed to Takeda for the U.S. market.



“The approval of ULORIC offers clinicians and their patients who have
hyperuricemia associated with gout a new treatment option that helps
prevent uric acid production,” said Nancy Joseph-Ridge, M.D.,
president, Takeda Global Research & Development Center, Inc., U.S. “In
the years that we’ve dedicated to studying patients who have gout, I
know that many patients go to their doctor during a flare not
understanding that gout is a chronic disease that needs to be managed
on a long-term, daily basis.”



Experts recognize that a goal in the treatment of chronic gout is the
reduction and maintenance of serum uric acid levels of less than 6
mg/dL. ULORIC, a xanthine oxidase inhibitor, effectively lowers levels
of serum uric acid in patients with hyperuricemia associated with
gout. It was studied and evaluated in multiple clinical trials
involving more than 4,000 subjects, in some for up to five years.



The largest, pivotal, phase 3 clinical trial, CONFIRMS, demonstrated
that ULORIC 80 mg was superior to ULORIC 40 mg and allopurinol 300/200
mg (67 percent, 45 percent and 42 percent, respectively) at achieving
the primary end point of serum uric acid less than 6.0 mg/dL at the
final visit (both p

ULORIC has an established safety profile with no dose adjustments
required in patients with mild-to-moderate renal or hepatic
impairment. The most commonly reported adverse reactions were liver
function abnormalities, nausea, joint pain and rash.



“We are pleased to offer a new treatment option, the first in 40
years, to the more than five million Americans who have hyperuricemia
associated with gout, fulfilling an unmet need,” said Alan MacKenzie,
president and CEO, Takeda Pharmaceuticals North America, Inc. “At
Takeda, we are deeply committed to developing strong clinical
programs and bringing to market innovative therapies, like ULORIC,
for patients. This approval is a significant milestone for Takeda, as
it marks our second approval within a month.”



About Gout and Hyperuricemia



Uric acid is an end-product created when the body breaks down
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, gout symptoms may become more frequent and patients may
develop large deposits of crystallized uric acid visible under the
skin, known as tophi.



About ULORIC(R) (febuxostat)



ULORIC works by blocking the enzyme xanthine oxidase. Xanthine
oxidase is responsible for the breakdown of the purine base,
hypoxanthine, to xanthine, and then to uric acid. By blocking this
enzyme, ULORIC helps prevent uric acid production, thereby lowering
elevated levels of serum uric acid.



Important Safety and Other Information



ULORIC is a xanthine oxidase inhibitor indicated for the chronic
management of hyperuricemia in patients with gout. ULORIC is not
recommended for the treatment of asymptomatic hyperuricemia.



ULORIC is contraindicated in patients being treated with
azathioprine, mercaptopurine, or theophylline. An increase in gout
flares is frequently observed during initiation of anti-hyperuricemic
agents, including ULORIC. If a gout flare occurs during treatment,
ULORIC need not be discontinued. Prophylactic therapy (i.e.,
non-steroidal anti-inflammatory drug (NSAID) or colchicine upon
initiation of treatment) may be beneficial for up to six months. A
higher rate of cardiovascular thromboembolic events was observed in
patients treated with ULORIC (0.74 per 100 patient-years) than
allopurinol (0.60 per 100 patient-years) in clinical trials. A causal
relationship with ULORIC has not been established. Monitor for signs
and symptoms of myocardial infarction (MI) and stroke. Transaminase
elevations have been observed in ULORIC-treated patients. No
dose-effect relationship for these transaminase elevations was noted.
Monitor liver function tests periodically. Adverse reactions
occurring in at least 1 percent of ULORIC-treated patients, and, at
least 0.5 percent greater than placebo, are liver function
abnormalities, nausea, arthralgia, and rash. Please see complete
Prescribing Information and visit the ULORIC Web site at
http://www.uloric.com.




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 http://www.tpna.com.



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, http://www.takeda.com.



Takeda Pharmaceutical Company Limited

[Via http://www.medicalnewstoday.com]

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