Savient gout drug faces approval delay

Savient Pharmaceuticals' shares dropped almost 30 percent on news that the FDA has extended the review of its gout drug by three months. The FDA requested more data on Krystexxa's cardiovascular risk, which the company said it provided. Additionally, Savient updated the drug's immunogenicity guidance, revised the drug's risk mitigation program and adjusted the suggested dosing schedule from every four weeks to ever two weeks.

"We believe the steps we have taken further clarify the favorable risk to benefit profile of pegloticase. Securing FDA approval remains our number one priority and we believe making these amendments is an important step toward achieving that goal... The Committee, our retained external experts, along with the management team, continue to believe in the relative benefit to risk profile of the safety and efficacy of this exciting product candidate when used in treating patients who suffer from treatment failure gout," said Paul Hamelin, President. If approved, the drug will be launched in the first quarter of 2010.

Separately, Savient announced that the company fired its CFO Brian Hayden. No reason was provided for his termination. Hayden will be replaced by David Gionco, who is Savient's current Vice President of Corporate Finance and Controller.

- here's Savient's release on the BLA
- and the statement on Hayden
- see the Forbes article

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