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Title: FDA Approves Romiplostim to Treat Chronic Immune Thrombocytopenic Purpura
URL: http://www.pslgroup.com/dg/229A42.htm
Doctor's Guide
August 22, 2008

ROCKVILLE, Md -- August 22, 2008 -- The US Food and Drug Administration (FDA) has approved romiplostim (Nplate) for patients with chronic immune thrombocytopenic purpura (ITP) who do not respond sufficiently to current treatments.

"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Janet Woodcock, MD, Center for Drug Evaluation and Research, FDA, Rockville, Maryland.

The approval is based on 2 randomised clinical trials of about 125 patients who had received at least 1 prior ITP treatment. One study enrolled patients who still had their spleen, the other enrolled patients who did not.

During 6 months of treatment, patients who received romiplostim had significantly higher platelet counts and maintained those higher counts compared with those who did not receive the drug.

The response to romiplostim was higher in those patients who still had their spleen than in those patients who had undergone a splenectomy. In those patients who did not receive romiplostim, only one experienced a sustained increase in platelet counts.

Safety concerns with romiplostim include fibrous deposits in the bone marrow and the possibility that once romiplostim is stopped, platelet counts could drop below what they were before beginning treatment.

Additional risks include blood clots due to excessive increases in platelets.

Furthermore, if romiplostim were given to patients with myelodysplasia, a risk for developing acute leukaemia may occur. In a study of 44 patients who had myelodysplasia and received romiplostim, 4 patients developed leukaemia.

Further clinical trials in patients with predisposing conditions for leukaemia will be needed to determine whether the development of leukaemia may relate to the use of romiplostim.

A Risk Evaluation and Mitigation Strategy (REMS) has been developed to address the risks of romiplostim therapy. The FDA has determined that a REMS is necessary for the benefits of romiplostim to outweigh the risks of the product.

The REMS will include a Medication Guide for patients and requires that all prescribers and patients enrol in a special program to track the long-term safety of romiplostim therapy.

SOURCE: The US Food and Drug Administration

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