FDA approves first new gout drug in 40 years

Breaking a therapeutic drought that has stretched over more than four decades, Takeda says it has won the FDA's approval of its new gout drug Uloric. Gout affects more than five million Americans who experience the painful effects of a buildup of uric acid in the blood and soft tissues.

Uloric works by blocking the xanthine oxidase enzyme, which inhibits production of uric acid. Back in 2005 the FDA turned down a marketing request for Uloric, noting data indicating a higher death rate and increased risk of heart problems for patients taking the therapy compared to patients receiving another gout drug. But a new and much larger Phase III trial resolved those concerns. The drug was discovered originally by Teijin Pharma,

"This FDA approval granted to Takeda Pharmaceuticals North America, along with the EMEA approval given last year to Ipsen, our licensee for febuxostat in Europe, marks a significant milestone for our global business," said Osamu Nishikawa, president of Teijin Pharma. "As to Japan and other areas including Asia, we are proceeding with our plans to develop febuxostat by ourselves as well as by collaborating with other companies. We will continue to strengthen our global operations by expanding areas where febuxostat is available and increase the presence of the product to be widely used by patients worldwide."

- check out Takeda's release
- read the story from WebMD