Gout Drug Receives Approval

Gout sufferers may find relief through the drug Krystexxa.

Gout sufferers may find relief through the drug Krystexxa, which was recently approved by the FDA.

Krystexxa is manufactured by Savient Pharmaceuticals Inc. and is the brand name for pegloticase. The drug is the first biologic developed to treat gout. It requires intravenous infusion every two weeks. Unlike the many pills on the market available to treat goat, the drug contains an enzyme that cannot be absorbed in pill form.

The drug works to lower uric acid in gout conditions.

“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, in a press release. “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.”

In stage three clinical trials, the drug successfully treated gout in an estimated 40% of more than 200 study participants. However, the FDA recommends that physicians give patients corticosteroids and antihistamines before an infusion to prevent allergic reactions. One out of four clinical trial participants experienced such reactions.