Takeda Wins U.S. Approval for First New Gout Drug in 40 Years

Takeda pharmaceutical co, Asia’s biggest drugmaker, won U.S. approval to sell the first new gout treatment in four decades.

The Food and Drug Administration cleared febuxostat, to be marketed as Uloric, to control excess uric acid in the blood that can build up in joints or soft tissues, the company said today in a statement. Regulators took more than four years to review the drug because of concerns about dosing and a potential increased risk of heart attack and stroke.

Takeda, based in Osaka, Japan, submitted the drug to regulators in December 2004 with former TAP Pharmaceutical Products partner Abbott Laboratories. Outside advisers to the FDA unanimously recommended approval in November, saying the estimated 6 million Americans suffering from gout need new treatment choices.

“This approval is a significant milestone for Takeda,” Alan MacKenzie, president of Takeda Pharmaceuticals North America, Inc., said in the statement. “We are pleased to offer a new treatment option to the more than five million Americans who have hyperuricemia associated with gout.”

Gout is a chronic condition marked by outbreaks of intense pain and swelling in the joints typically starting in the big toe, sometimes spreading to knees or fingers. It most often affects men, especially those ages 40 to 50, and people who have had an organ transplant. Gout was once known as a disease of kings because the risks increase if people are overweight, eat a lot of meat or indulge in alcohol.

Dosage Concerns

Takeda tested its drug against generic allopurinol, the most commonly prescribed treatment to lower levels of uric acid in the blood. While allopurinol was approved by the FDA in 1966 for use in a range of doses, concerns that the drug may cause rashes or a deadly skin reaction have discouraged doctors from using the highest, most effective doses, according to briefing documents released by Takeda before the advisory panel meeting.

Takeda had initially sought approval for 80-milligram and 120-milligram oral doses of febuxostat. Regulators were worried about a higher number of cardiovascular side effects in patients taking the drug, and they asked for a new study using only 80- milligram and 40-milligram doses. Takeda stuck with the lower strengths when both worked in the study and weren’t linked to a higher rate of heart attacks or strokes.