Savient's KRYSTEXXA receives FDA approval for chronic gout in adult patients refractory to conventional therapy

Sep 15 2010

Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA™ (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.  Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

"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," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals.  "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease."

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.  Specific timing for the launch of KRYSTEXXA will be determined within the context of the Company's commercialization plan and by the progress and status of the Company's efforts to pursue a strategic transaction for the sale of Savient. KRYSTEXXA was granted an Orphan Drug designation by the FDA in 2001 that the Company expects will provide the drug seven years of orphan drug market exclusivity. The composition, manufacture and methods of use and administration of KRYSTEXXA are also the subject of a broad portfolio of patents and patent applications that the Company expects will provide protection into 2026.