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Pegloticase (Krystexxa – Savient), a PEGylated urate oxidase enzyme, has been approved by the FDA for intravenous (IV) treatment of chronic symptomatic gout in adults who have not responded to maximum doses of a xanthine oxidase inhibitor, such as allopurinol (Zyloprim, and others). Pegloticase is the second new drug approved for gout in more than 40 years; a new xanthine oxidase inhibitor, febuxostat (Uloric), was approved in 2009.

Until the recent introduction of febuxostat (Uloric), no new drugs had been marketed for treatment of gout in the past 40 years. Colchicine, which has been available for decades as an unapproved drug, has now been approved by the FDA (Colcrys) for treatment and prophylaxis of gout flares. It was approved earlier only in combination with probenecid (Colbenemid, and others). The goals of gout treatment are three-fold: treating acute disease, preventing flares and reducing uric acid stores.

Febuxostat (Uloric - Takeda), a xanthine oxidase inhibitor, has been approved by the FDA for chronic management of hyperuricemia in patients with gout. It is the first drug marketed for treatment of gout in 40 years. Febuxostat is structurally unrelated to allopurinol, the only other commercially available inhibitor of xanthine oxidase. Xanthine oxidase inhibitors decrease serum urate concentrations by decreasing urate synthesis.

Rasburicase (Elitek - Sanofi-Synthelabo), a recombinant form of urate oxidase derived from the fungus Aspergillus flavus, has been approved by the FDA for intravenous (IV) management of hyperuricemia associated with tumor lysis syndrome in pediatric patients.