Long-term use potential for romiplostim

22 June 2008

Amgen has reported strong results from an ongoing, open-label extension study on the long-term safety and efficacy of romiplostim in adult patients with chronic immune thrombocytopenic purpura, a chronic autoimmune disorder characterized by low platelet counts in the blood. The updated findings continue to show that the agent increased and sustained platelet counts with extended treatment, and reduced the need for concurrent and rescue ITP medications, noted the US biotechnology major.

Data from the long-term study were presented at the 13th Congress of the European Hematology Association, held in Copenhagen, Denmark, and show that, overall, 87% of patients achieved a platelet response defined as a count of 50,000 platelets per microliter or doubling of the count. The overall median baseline count was 17,000 platelets per microliter. The average treatment period was 65 weeks, and the longest treatment duriation was 156 weeks.

"Currently, romiplostim is the only thrombopoietic treatment for adult chronic ITP for which there is three years of follow-up data," said UK hematologist Adrian Newland. "This is the longest ITP study and the findings demonstrate the potential of romiplostim as a long-term treatment option for a patient population with limited treatment options," he added.

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