A US Food and Drug Administration Advisory panel voted 12-0 this week to recommend approval of the first new gout drug in 40 years: Takeda Pharmaceutical's febuxostat (Uloric®). One panel member abstained.
The Arthritis Advisory Panel had been concerned because early trials found a higher risk of death and heart problems associated with febuxostat, but a much larger clinical study commissioned by the company found that cardiac risk with febuxostat was not any higher than those with allopurinol.
According to Nancy Joseph-Ridge, head of research and development for Takeda, one advantage of the new drug is that it is safer and more effective than allopurinol for patients with kidney problems. “A lot of gout patients suffer from kidney disease,” said Dr. Joseph-Ridge. “This is something of real need. Patients who could not take the other drug will now have treatment.”
The vote followed presentations by Takeda Global Research & Development Center, Inc., the FDA, and invited guest speakers.
Febuxostat was approved earlier this year by the European Medicines Agency (EMEA) and is marketed there by Ipsen, an international specialty pharmaceutical group, as Adenuric®.