Savient Pharma Refiles Biologics License Application For Krystexxa

The resubmission includes data from three consecutive manufacturing validation batches of the pegloticase active pharmaceutical ingredient (API) drug substance, additional and improved analytical methods for the control and release of pegloticase API and Krystexxa and other data which are designed to address the issues cited by the FDA in its July 31, 2009 Complete Response Letter (CRL).

Additionally, it also includes a safety update from the remaining studies that were ongoing at the time of the previous 120-Day safety update. Additional documents included in the resubmission are proposals for product labeling and prescribing information, REMS program materials and a patient Medication Guide, all of which were requested in the CRL and the company believes are consistent with previous discussions with the FDA associated with the company’s September 14, 2009 Type A meeting.

Paul Hamelin, president of Savient, said: “We believe that this resubmission combined with the submissions made and planned by our third party contract manufacturer fully addresses the deficiencies and observations raised and provides the additional materials requested in the Complete Response Letter that we received from the FDA on July 31, 2009, which were further clarified in our meeting with the FDA on September 14, 2009.

“We look forward to the advancement of this novel biologic through the regulatory review process including the potential reinspection of our contract manufacturer in the months ahead. We continue to believe that Krystexxa has the potential to fill a void in an area of significant unmet medical need and are confident that this is a quality resubmission package that can support a favorable determination by the FDA.”