The FDA also stated that the format and content of Savient's proposed safety update, which will include additional data collected from the KRYSTEXXA Open Label Extension study, is acceptable to the FDA.
During the meeting, the Company was informed that the review cycle for the resubmission would include the review of all data to fully address all issues identified in the CRL, including the final product labeling and the REMS materials. Since the resubmission will include REMS materials, this is subject to a Class 2 review cycle, meaning simultaneous approval of all components of our filing within six months of the date of our resubmission.
"We look forward to continuing to work with the FDA and executing on our resubmission strategy to the Complete Response Letter so that we can move forward with delivering this important therapy to treat chronic gout patients who are suffering from this crippling, debilitating disease and who have no other treatment options," commented Mr. Hamelin.
Savient also stated that the official minutes of this Type A meeting with the FDA will be made available to the Company within approximately 30 days from the date of the meeting.
Conference Call Information
Savient's management team will host a live conference call and Webcast today at 9:00 a.m. Eastern Time/6:00 a.m. Pacific Time to further discuss the results of the Type A meeting with the FDA. To participate by telephone, please dial 888-349-9587 from the U.S. or 719-457-2640 for international callers. The conference identification number is 8540659. The live and archived Webcast can be accessed on the investor relations section of the Savient Website at www.savient.com. Please log on to Savient's website
|SOURCE Savient Pharmaceuticals, Inc.|
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