Amgen’s risk plans for Nplate
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen's biologic Nplate (romiplostim) will have a Risk Evaluation and Mitigation Strategy that will include a comprehensive patient educational program plus financial assistance for those who cannot afford the drug, according to an Amgen release prematurely issued July 14, which states that the drug had been approved. Amgen later reports that FDA will miss the July 23 user fee date for the product, submitted for treatment of thrombocytopenia in adults with chronic immune thrombocytopenic purpura. The user fee had been pushed back from April 23 after the firm submitted an extensive risk management plan. Nplate is widely expected to gain approval shortly; FDA's Oncologic Drugs Advisory Committee voted unanimously in favor of the biologic in March (1Pharmaceutical Approvals Monthly June 2008)