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Savient on track to refile gout therapy Krystexxa in early 2010

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Savient Pharmaceuticals is well on its way to resolving issues raised in an FDA "complete response" letter for gout therapy Krystexxa (pegloticase) and plans to refile the BLA by early 2010 as planned, President Paul Hamelin said Sept. 16. Issues raised in the letter related to chemistry, manufacturing and controls; pre-approval inspection of the firm's third-party manufacturer; a safety update; proposed labeling; and the product's Risk Evaluation and Mitigation Strategy. It's a hefty list but all doable in time for the resubmission, the exec said, noting positive signals from FDA reviewers at a Sept. 14 meeting (1"The Pink Sheet" DAILY, Sept. 16, 2009)
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