Savient Pharmaceuticals, Inc., of East Brunswick, N.J., has received FDA clearance to market Krystexxa (pegloticase) as a treatment for chronic gout in adult patients refractory to conventional treatment.
The company said it expects the medication to become available by prescription in the United States later this year.
The recommended dose and regimen of the drug is 8 mg administered as an IV infusion every two weeks. It should not be given as an IV push or bolus.
In two clinical trials, patients were randomized to receive pegloticase every two or four weeks or placebo. The primary efficacy endpoint was the proportion of patients who achieved plasma uric acid levels below 6 mg/dL for at least 80% of the time during month 3 and month 6. During the first six months of treatment, 47% and 38% of patients in the pegloticase arms of the two studies achieved the primary efficacy endpoint compared with 0% in the placebo arms.