Amgen’s platelet simulator Nplate® (romiplostim) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) who are refractory to standard therapy.
As an approval requirement, the FDA has ordered a Risk Evaluation and Mitigation Strategy (REMS) to assess post-marketing risks and benefits. To monitor long-term safety of Nplate, REMS includes a Medication Guide requiring all prescribers and patients to enroll in a registry.
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