Washington, February 15: The Food and Drug Administration (FDA) has authorized the sale of Uloric, a drug for the treatment of gout. This is the first drug for the disease that has been approved by FDA in the past four decades.

The FDA has approved febuxostat, to be marketed as Uloric, for the treatment of gout. Gout is a chronic disease, characterized by outbreaks of intense pain and swelling in the joints caused by a build-up of uric acid in the joints. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout.

The disease most commonly affects men, especially those between the age group of 40 to 50, and the people who have had an organ transplant. This drug blocks the enzyme xanthine oxidase, which is responsible for the breakdown of the purine base to uric acid. Blocking of this enzyme regulates the uric acid production, thereby lowering elevated levels of blood uric acid.

Takeda Pharmaceuticals is really excited after the approval. “This approval is a significant milestone for Takeda. We are pleased to offer a new treatment option, the first in 40 years, to the more than five million Americans who have hyperuricemia associated with gout, fulfilling an unmet need,” said Alan MacKenzie, president and CEO, Takeda Pharmaceuticals North America Inc.

The use of highly effective doses of allopurinol, the drug approved by the FDA in 1966, to lower the levels of uric acid in the blood had been discouraged by the doctors in the past few years because of concerns that the drug may cause rashes or a deadly skin reaction. Thus, Uloric comes as a substitute to the drug, much to the relief of the patients.

The FDA arthritis advisory committee unanimously voted in favor of approval of Uloric for chronic gout in November. It took them more than four years to review the drug because of concerns of increased risk of heart attack and stroke with high doses of the drug.

Takeda had initially applied for an approval for the 80 and 120 milligrams oral doses but later stuck to the lower doses of 80 and 40 milligrams as a FDA recommended study with the lower doses showed no signs of higher rate of heart attacks or strokes.

Febuxostat was created by Japan’s Teijin Ltd. and Takeda has the rights to sell it in the U.S. and Canada. In Europe, the drug was approved in last May, and Ipsen SA of France has the rights for distribution and sales in Europe.

Takeda have not yet commented on the business potential for Uloric. Takeda sells the heartburn drug Prevacid and the diabetes pill Actos, among other prescriptions.