Savient Pharmaceuticals, Inc. (SVNT), Sunday, said it received a complete response letter from the U.S. Food and Drug Administration rejecting its Biologics License Application for KRYSTEXXA or pegloticase, as a treatment for chronic gout in patients refractory to conventional therapy.
Response letter cites deficiencies with the chemistry, manufacturing and controls section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy.
Savient intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter.
One of the issues raised by the FDA in the complete response letter indicate that the data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase 3 clinical trials.
The complete response letter included additional CMC comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial. production.
The company, however, believes that its resubmission would respond to all of the deficiencies cited in the compete response letter.
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