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Savient Suggests More Restrictive REMS For Pegloticase In BLA Amendment

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Savient has made a clever anticipatory move that could help avoid a "complete response" letter for its BLA for pegloticase, a therapy for treatment-failure gout. The firm submitted major amendments just one month prior to its scheduled advisory committee hearing, including a revised proposed Risk Evaluation and Mitigation Strategy that adds a certification program

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