UPDATE 2-US FDA panel backs Takeda gout drug, wants more data

(Adds company comment)

By Susan Heavey

SILVER SPRING, Md., Nov 24 (Reuters) - The U.S. Food and Drug Administration should approve Takeda Pharmaceutical Co Ltd's (4502.T) experimental gout drug as long as the agency requires further safety studies, an FDA advisory panel recommended on Monday.

The Japanese drugmaker is seeking U.S. approval to market its drug febuxostat under the brand name Uloric, which if approved, would be the first new treatment for the arthritic disease in more than 40 years, the company said.

Gout is a type of arthritis in which uric acid accumulates in the blood and causes painful, swollen joints. The acid can also cause kidney stones, and if not treated gout can damage both the kidneys and joints, according to the National Institutes of Health.

Takeda estimates between 3 million and 5 million Americans have the condition, which is prone to flaring up.

Overall, the FDA panel said having a new drug could help treat patients who do not improve with current treatments as doctors continue to struggle with treating what is one of the world's oldest know diseases.

"I think there is quite a bit of evidence that this could be a useful agent," said panelist Dr. Nancy Olsen, a professor at the University of Texas Southwestern Medical School.

Takeda first sought FDA's approval in 2004. Instead, the FDA called for additional data because of the agency's concerns about possible heart risk with the drug.

At the time, two studies showed more heart problems in patients given either 80-milligram or 120-milligram doses of febuxostat compared to those given allopurinol, a currently-approved gout treatment. When the company completed a third study of 40-milligram and 80-milligram doses of its drug, it did not find an increased heart risk.

Allopurinol is sold in the United States by privately-held Prometheus Laboratories Inc under the name Zyloprim.

Limitations to the early data made it difficult to interpret, said Dr. Jane Gilbert, a medical reviewer in FDA's arthritis drugs division. But other FDA cardiovascular and kidney experts found no signal of heart problems in the new findings, she said.

Still, the data "does not enable one to exclude the possibility of an increased risk with febuxostat," although it does show the drug is effective, she said.

The panelists agreed and called on the FDA to require the company to gather additional data to assess possible side effects, including heart risks.

Baylor University Medical Center professor Dr. John Cush, echoing other panel members, expressed concern that Takeda did not study "real work risk" of heart problems, because it excluded those who are more susceptible to such side effects.

"We don't have good information on potential users ... We don't know the long term," said another panelist, Wake Forest University School of Medicine professor Dr. Curt Furberg, who cited the company's 6-months of data.