Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC^® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout. ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market. 

Gout, a form of arthritis, is a chronic debilitating arthritic condition caused by above normal levels of serum uric acid in the blood. 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 effects people during the night while sleeping. Over time, attacks become more frequent and severe and can move into other joints, such as the ankles, knees, heels, wrists, elbows and fingers.

"The first time I experienced a gout attack the pain was excruciating, and it was something I never wanted to experience again.  I spent years avoiding food I believed would trigger another attack, but they still came back," says Ralph Zarboni "Today, with ULORIC, I am living my life pain free." 

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 (67% and 42%, respectively) at achieving the primary end point of sUA levels less than 6.0 mg/dL at the final visit (both p<0.001).

"Modifying diet, losing weight and limiting alcohol consumption do little to manage gout.  For many patients, dietary restrictions are not enough and they need medical treatment," says Dr. William Bensen, Clinical Professor at McMaster University and Active Rheumatology Staff at St. Joseph's Hospital, Hamilton. "With ULORIC, now available, physicians have another option to help patients manage the debilitating and painful aspects of this disease."

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 safety and efficacy profile that makes it an appropriate option for patients who have elevated sUA (serum uric acid) levels, have mild-to-moderate renal or hepatic impairment, or are unresponsive to other treatment options.

"Takeda is committed to striving toward better health for individuals by providing innovative therapies," says Paul Friel, general manager and president, Takeda Canada, Inc.  "We are pleased to offer a new treatment option, the first in 40 years, to patients with gout as a way to help treat their underlying medical condition and provide them relief from this intensely painful disease."     

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 recommended for the treatment of high uric acid without a history of gout.