Patients to have access to first new treatment option in more than 40
MISSISSAUGA, ON, Sept. 8, 2011 /CNW/ - The Newfoundland and Labrador
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 Newfoundland and Labrador Prescription Drug
Program for the treatment of patients with symptomatic gout who have
documented Drug-induced Hypersensitivity Syndrome to allopurinol,
effective August 1st, 2011.
"The Newfoundland and Labrador government's decision to list ULORIC
under the Prescription Drug Program demonstrates the province's
commitment to ensuring Newfoundland and Labrador 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 disease."
ULORIC (febuxostat, tablet, 80mg) is listed for patients with
symptomatic gout who have documented Drug-induced Hypersensitivity
Syndrome to allopurinol. Drug-induced Hypersensitivity Syndrome is
characterized by a major skin manifestation, fever, multi-organ
involvement, lymphadenopathy, and hematological abnormalities
(eosinophilia, atypical lymphocytes). The onset of symptoms usually
occurs two to eight weeks after therapy initiation of the causative
drug. At least three of the above listed characteristics should be
present including the involvement of at least one extracutaneous organ
Takeda Canada, Inc. hopes that other provinces will follow Newfoundland
and Labrador, 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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