An FDA advisory committee voted unanimously to back Takeda's application for the first new gout drug in 40 years. Uloric is designed to reduce levels of uric acid, which triggers gout. Initial fears that the drug was linked to an increased risk of death and heart attacks was addressed in a large late-stage trial, which found no difference in heart risk when compared to patients taking allopurinol, the standard therapy now available.
The committee recommended follow-up safety studies following commercialization. According to Takeda, the drug works better for patients with kidney problems, a significant segment of the market.
"A lot of gout patients suffer from kidney disease," said Dr. Nancy Joseph-Ridge, head of research and development for the company. "This is something of real need. Patients who could not take the other drug will now have treatment."
- check out the AP report