Savient Pharmaceuticals, Inc. (SVNT) announced Tuesday that the FDA approved KRYSTEXXA indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. The drug, which has orphan status of the FDA is expected to be prescribed in the US later in the year.
Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid.
Savient said the specific timing of the launch would be determined by its commercialization plan, as well as tied to its efforts to pursue a strategic transaction for the sale of Savient.
KRYSTEXXA-pegloticase is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
KRYSTEXXA was granted an Orphan Drug designation by the FDA in 2001 that the Company expects would provide the drug seven years of orphan drug market exclusivity. KRYSTEXXA is also covered by patent applications that the company expects would provide protection into 2026.
Paul Hamelin R.Ph., President of Savient Pharmaceuticals said,"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy,"
The company said a statistically significant proportion of parents achieved a lowering of serum uric acid levels in clinical trials. The patients achieved a complete response for the resolution of tophi within the first six months of the therapy.
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 less than 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 KRYSTEXXA arms of the two clinical studies achieved the primary efficacy endpoint, compared with 0% of patients in the placebo arm.
The effect of treatment with KRYSTEXXA on tophi was a secondary efficacy endpoint of the clinical studies. Tophi are deposits of monosodium urate crystals in people with longstanding high levels of uric acid in the blood. A pooled analysis of data from both clinical studies at month 6 demonstrated that 45% of patients with tophi treated with KRYSTEXXA every 2 weeks achieved a complete response, compared to 8% of patients receiving placebo.
Savient expects KRYSTEXXA to be available by prescription in the U.S. later this year and believes it is well advanced in its preparations for the U.S. launch of KRYSTEXXA.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.