Takeda Pharmaceutical Co. won US approval to sell the first new treatment option for chronic management of hyperuricemia in patients with gout in more than 40 years, the company reported.
 
Uloric (febuxostat), as the drug was called, lowers uric acid in the blood of patients with gout, a chronic condition affecting more than 5 million Americans. It works by inhibiting xanthine oxidase, the enzyme responsible for uric acid production.
 
“This approval is a significant milestone for Takeda. We are pleased to offer a new treatment option to the more than five million Americans who have hyperuricemia associated with gout,” Alan MacKenzie, president of Takeda Pharmaceuticals North America, Inc., said in a statement.
 
Gout is marked by outbreaks of intense pain and swelling in the joints caused by high levels of uric acid that are deposited on the articular cartilage of joints, tendons and surrounding tissues. It mostly affects men, especially those ages 40 to 50, and people who have had an organ transplant. Risk factors of the condition are obesity, heavy meat and alcohol use.
 
Uloric was discovered by Teijin Pharma, a Japanese company. Although, regulators were worried about a higher number of cardiovascular side effects, in clinical trials, the drug was more effective than both placebo and allopurinol – the other approved treatment for hyperuricemia in patients with gout – in lowering serum acid levels.
 
Uloric is available in 80-milligram and 120-milligram oral doses. Serious side effects of the drug are liver function abnormalities, nausea, joint pain and rash, according to the company