The FDA has approved Nplate (romiplostim) for the treatment of thrombocytopenia in splenectomized and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP).
In two Phase III studies of the drug, which works by raising and sustaining platelet counts, the overall response rate for romiplostim was 79% in splenectomized patients and 88% in non-splenectomized patients. Platelet counts were raised and sustained in the six-month studies, and patients were able to reduce or discontinue their use of concomitant ITP medications and emergency medications.
Nplate's manufacturer, Amgen, also announced that it is launching the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program, to provide comprehensive access, support, and education for chronic ITP patients and their caregivers, and health care providers. The program is part of the Risk Evaluation and Mitigation Strategy developed by Amgen in partnership with the FDA to assure safe use of romiplostim while minimizing risk, and will facilitate appropriate use of the drug, provide patient support through education and resources, and help with ongoing follow-up through safety data collection.
Also through the program, eligible patients who are uninsured, underinsured, or unable to afford their insurance co-payments may be able to receive reimbursement support and other assistance from Amgen, the company noted.
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