Amgen announces phase III romiplostim results

Amgen has announced the results of a phase III clinical study of romiplostim – also known as AMG 531 – in splenectomised adult patients with chronic immune thrombocytopenic purpura (ITP).

The company report that the compound met its primary endpoints, with increased and sustained platelet counts and patients taking concurrent medicaiton for their ITP, such as corticosteroids, being able to reduce or stop taking these drugs.

Amgen has filed for regulatory approval for the compound as a treatment for thrombocytopenia in adults with chronic ITP in the European Union, the US, Australia and Canada.

Dr Terry Gernsheimer, associate professor of medicine in the haematology division of the University of Washington School of Medicine, said: “Romiplostim is an investigational therapy that stimulates platelet production in a manner similar to the body’s natural hormone thrombopoietin, and is currently being evaluated for its ability to increase the platelet count by increasing platelet production in ITP.”

He added that currently available treatments for ITPs operate by decreasing the destruction of platelets by the immune system, which is not sufficient for patients experiencing inadequate production of platelets as a result of the disease.

Last week, Amgen reported that it is currently in negotiations with the US Food and Drug Administration regarding a potential update to the labelling on its erythropoiesis stimulating agents.