KRYSTEXXA (pegloticase) 8mg/1mL injection by Savient
The FDA has approved Krystexxa (pegloticase injection, from Savient), a PEGylated uric acid specific enzyme, for the treatment of chronic gout in adult patients refractory to conventional therapy. This approval was based on data from two multicenter, replicate, randomized, double-blind, placebo-controlled clinical studies of six months duration. Patients were randomized to receive Krystexxa every 2 weeks or every 4 weeks or placebo in a 2:2:1 ratio. The primary endpoint in both trials was the proportion of patients who achieved plasma uric acid (PUA) <6mg/dL for at least 80% of the time during month 3 and month 6. During the first six months of treatment, 47% (p<0.001) and 38% (p<0.001) of patients in the Krystexxa arms of the two clinical studies achieved the primary efficacy endpoint, compared with 0% of patients in the placebo arm.
Krystexxa is expected to be available later in 2010 in a 8mg/1mL dosage strength.