Despite a 14-1 advisory panel recommendation, the FDA has issued a Complete Response letter to Savient Pharmaceuticals for its gout treatment Krystexxa. The letter cites deficiencies with the CMC section of Krystexxa’s BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS). Savient plans to immediately request a meeting with the FDA to discuss and clarify the issues raised in the letter. The compan...