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Savient gout drug approved

Savient Pharmaceuticals has received US Food and Drug Administration approval for its gout drug Krystexxa

Savient Pharmaceuticals has received US Food and Drug Administration (FDA) approval for its gout drug Krystexxa (pegloticase), which the company says will be the first treatment on the US market that offers significant clinical improvement within six months of the start of therapy.

The drug, which is a PEGylated uric acid-specific enzyme, is also the first product in the US to be approved for chronic gout that is not successfully treated by conventional therapy.  It has been cleared for marketing as a treatment for adult patients whose disease is refractory to conventional therapy with xanthine oxidase inhibitors at the maximum appropriate dose.

Krystexxa is also approved for use in patients in whom xanthine oxidase inhibitors are contraindicated. The 8mg formulation is administered by intravenous infusion every two weeks.

Savient said it plans to launch Krystexxa later this year, with specific plans "to be determined within the context of the company's commercialisation plan and by the progress and status of the company's efforts to pursue a strategic transaction for the sale of Savient."

The product was granted orphan drug status by the FDA in 2001, which will likely mean seven years of marketing exclusivity in the US following the launch.

The drug will be marketed under a Risk Evaluation and Mitigation Strategy approved by the FDA that includes a communication plan for healthcare providers and a medication guide for patients regarding anaphylaxis and infusion reactions. In addition, the labelling for the product will carry a boxed warning -- the strongest type of caution that can be required by the FDA -- regarding the risks.

As part of the approval requirements, Savient is required to conduct a one-year post-approval observational safety study in 500 patients.

15th September 2010

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