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