Amgen announces positive romiplostim data in chronic ITP

Amgen has announced results from an ongoing study of the long-term safety and efficacy of romiplostim as a treatment for adult patients with chronic immune thrombocytopenic purpura (ITP).

The company reports that the updated results show the compound to increase and sustain platelet counts with extended treatment, while providing a reduced need for concurrent and rescue medications for ITP.

Data presented to the congress of the European Haematology Association showed that 87 per cent of patients achieved a platelet response, with this measure described as a doubling of the baseline platelet count or a count of 50,000 platelets per microlitre.

Professor Adrian Newland of the Department of Haematology at the Royal London Hospital, said: “Currently, romiplostim is the only thrombopoietic treatment for adult chronic ITP for which there is three years of follow-up data.”

He added that the findings from the longest ITP study show the potential of romiplostim as a long-term therapy for a condition which currently has limited treatment options.

In April 2008, Amgen was notified by the US Food and Drug Administration that its priority review for the biologics license application for romiplostim had been moved back to July 23rd 2008 after the firm submitted a new risk management programme for the compound.