Takeda gout drug Uloric loses first-line approval after FDA confirms death risks

FDA has slapped a boxed warning on Takeda's gout drug Uloric due to an increased risk of death. (FDA)

Takeda's gout drug Uloric just got pushed out of the first-line treatment club, thanks to a red flag on safety.

After sifting postmarketing data, the FDA decided Uloric does carry an increased risk of death compared to the older gout drug allopurinol. The agency has slapped a boxed warning on Uloric's label and is limiting Uloric’s use to patients “who have failed or do not tolerate allopurinol.”

That means the Takeda medication will be forced into a smaller population of some 8.3 million adult gout patients in the U.S. And that could cut seriously into the growth Uloric's been posting for the Japanese drugmaker.


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“We believe the label updates are appropriate to ensure physicians and patients have comprehensive and accurate information to make informed treatment decisions,” a Takeda spokeswoman told FiercePharma in an emailed statement.

Uloric was approved by the FDA in 2009 after two failed attempts in 2005 and 2006. The agency turned Uloric back then because of cardiovascular problems that cropped up in clinical trials. A follow-up trial Takeda ran for its third run at approval didn’t raise the same safety flag, so the FDA gave Uloric a green light, but included the CV safety data in the “Warning and Precaution” section of its label.

The FDA also required Takeda to run a large postmarketing safety study—and the data once again showed reason for worry.

RELATED: Takeda hits FDA snag on Ninlaro, but its growth still helps drive revenue hike

“The imbalance in cardiovascular deaths between the two treatments was unexpected and warrants further analyses,” William White of the University of Connecticut School of Medicine, the lead investigator of the postmarket study, said in a statement last March.

In the 6,190-patient trial, Uloric’s rates of CV-related death and death from all causes were notably higher than those for allopurinol. The findings prompted a petition from nonprofit consumer advocacy group Public Citizen calling on the agency to pull Uloric’s approval.

Uloric is one of the growing drugs in Takeda’s portfolio. In the nine months ended in December, it raked in 40.5 billion Japanese yen ($366 million), up 15.7% year over year, with almost all sales coming from the U.S. The boxed warning and restriction to second-line use could put the drug’s growth in jeopardy.

Editor's Note: The story has been updated with a statement from Takeda.

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