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Krystexxa resubmission for gout on track for first quarter

 
• By Katie McQue

Savient Pharmaceuticals says that it is on track to re-file the BLA seeking an indication in chronic and treatment-failure gout for Krystexxa (pegloticase) in the first quarter of this year. It received a complete response letter for the drug from the US FDA last July.

Savient Pharmaceuticals says that it is on track to re-file the BLA seeking an indication in chronic and treatment-failure gout for Krystexxa (pegloticase) in the first quarter of this year. It received a complete response letter for the drug from the US FDA last July.

Once submitted, the company expects to be subject to a "Class 2" resubmission review cycle, meaning that an FDA decision...

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