The FDA has approved the drug Uloric for the chronic management of hyperuricemia. The once-daily, oral medication is the first new treatment option for gout sufferers in more than 40 years.
Teijin Pharma Limited of Tokyo discovered the medication and licensed Uloric to Takeda for the U.S.
market.
"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," said Dr Nancy Joseph-Ridge, president of Takeda.
Uloric reduces and maintains the serum uric acid levels in patients with hyperuricemia associated with gout. The drug was evaluated in multiple clinical trials that involved more than 4,000 participants over the span of five years.
The medication has a 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.
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