Patients to have access to first new treatment option in more than 40
MISSISSAUGA, ON, Sept. 8, 2011 /CNW/ - The Alberta government announced
that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum
uric acid levels in patients with gout, is now covered by special
authorization under the Alberta Health and Wellness Drug Benefit List
for the treatment of symptomatic gout in patients who have documented
hypersensitivity, or severe intolerance to allopurinol, and
intolerance, or lack of response to sulfinpyrazone and probenecid,
effective July 1, 2011.
"The Alberta government's decision to list ULORIC under the Alberta
Health and Wellness Drug Benefit List demonstrates the province's
commitment to ensuring Alberta patients who meet the criteria have
access to optimal treatment," said Laurene Redding, Director,
Government & Economic Affairs, Takeda Canada, Inc. "By providing access
for these patients, the province is helping to improve quality of life
for sufferers and halting the symptoms of this chronic and debilitating
ULORIC (febuxostat, tablet, 80mg) is listed for patients with
symptomatic gout who have documented hypersensitivity, or severe
intolerance to allopurinol, and intolerance, or lack of response to
sulfinpyrazone and probenecid. Special authorization may be granted for
six months. Coverage cannot be considered for lack of response to
allopurinol. All requests for febuxostat must be completed using the
Febuxostat Special Authorization Request Form (ABC 31376).
Takeda Canada, Inc. hopes that other provinces will follow Alberta,
Saskatchewan and Quebec's lead in ensuring that people suffering from
gout who rely on provincial drug plans will have access to ULORIC.
Gout, a form of arthritis, is caused by above normal levels of serum
uric acid in the blood.1 Uric acid is a natural waste product that when it accumulates, forms
crystals and deposits in the joints. These deposits result in
inflammation causing pain, swelling, redness and tenderness of the
area. In many people, gout initially attacks the joint of the big toe
and often affects people during the night while sleeping. Over time,
attacks become more frequent and severe and can move into other joints,
such as the ankle, knee, foot, hand, wrist, and elbow.2
The underlying cause of gout is hyperuricemia, a condition of high
levels of uric acid in the blood, and the key target in the treatment
and management of gout. ULORIC lowers the level of serum uric acid in
the blood by stopping the body from turning purines into uric acid. In
clinical trials, ULORIC 80 mg was superior to allopurinol 300/200 mg at
achieving the primary end point of sUA (serum uric acid) levels less
than 360 µmol/L at the final visit (both p<0.001).
Health Canada's approval of ULORIC was based on multiple phase III
clinical trials. A diverse patient population of more than 4,000
subjects was studied, and in some cases for up to five years. ULORIC
has a proven efficacy profile that makes it an appropriate option for
patients who have elevated sUA levels, have mild-to-moderate renal or
hepatic impairment, or are unresponsive to other treatment options.
ULORIC has an established safety profile with no dose adjustments
required in patients with mild-to-moderate renal or hepatic impairment.
As with all medications, ULORIC has an established risk to benefit
profile and so patients should speak to their physician to determine if
ULORIC is right for them. The possible side effects that can occur in
people who use ULORIC include liver problems, diarrhea, nausea,
dizziness, joint pain, gout flares, and rash. Also, a small number of
heart attacks, strokes and heart-related deaths were seen in clinical
studies. It is not certain that ULORIC caused these events. ULORIC is
not indicated for the treatment of high uric acid without a history of
ULORIC was approved for use in Canada in September 2010. ULORIC is
indicated to lower serum uric acid levels in patients with gout.
About Takeda Canada, Inc.
Takeda Canada, Inc. is a division of Takeda Pharmaceutical Company
Limited, the largest pharmaceutical company in Japan. The Canadian
headquarters were established in Mississauga, Ontario, in 2009. Takeda
Canada, Inc. currently distributes Actos® for the treatment of type 2 diabetes and DEXILANT for the treatment of
gastroesophageal reflux disease. The company seeks to enhance the lives
of Canadians by providing innovative new products for metabolic,
cardiovascular, oncology, central nervous system, and other related
conditions. Takeda is committed to striving toward better health for
individuals and progress in medicine. To learn more about Takeda
Canada, Inc. visit www.takedacanada.com.
ULORIC® is a registered trademark of Teijin Pharma Limited and used
under license by Takeda Pharmaceuticals America, Inc.
DEXILANT is a trademark of Takeda Pharmaceuticals North America Inc. and
used under license by Takeda Canada, Inc.
1 Public Health Agency of Canada. Arthritis in Canada - An Ongoing
Challenge. http://www.phac-aspc.gc.ca/publicat/ac/ac_2e-eng.php. Accessed July 2011.
2 The Arthritis Society. http://www.arthritis.ca/types%20of%20arthritis/gout/default.asp?s=1&province=ca Accessed July 2011.
SOURCE Takeda Canada, Inc.
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