The Federal Drug Agency has approved the first gout drug in 40 years. Takeda Pharmaceuticals Co. has won the approval to sell Uloric in the United States.

The drug is administered for the chronic management of hyperuricemia in gout patients. The drug blocks an enzyme called xanthine oxidase and lowers elevated uric acid levels, said the Japanese company that makes Uloric.

The FDA regulators reviewed febuxostat, marketed as Uloric, for about four years. It took them so many years because of fears about high risks dosing and a potential increased risk of heart attack and stroke.

The drug was submitted to FDA regulators in 2004 by Osaka-based Takeda Pharmaceuticals and partner Abbott Laboratories. Alan MacKenzie said the FDA approval is “a significant milestone” for the Japanese drug maker and also good news for the nearly 6 million Americans that suffer from gout.

Three years ago, the FDA refused Takeda’s request to approve Uloric arguing that the number of deaths among patients who take Uloric is slightly higher than in patients who take another gout drug called allopurinol.

Answering the FDA’s request, Takeda addressed the safety issue by carrying on a large new phase III clinical trial that enrolled more patients than the two previous phase III trials combined. Fortunately for Takeda, the new trial went well and Uloric was approved.

Gout is a chronic illness which manifests through outbreaks of intense pain and swelling in the joints. Men between 40 and 50 are affected the most.  People who had an organ transplant and those who eat a lot of meat and drink a lot of alcohol are more exposed to the illness.