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Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Date:2/6/2009

First and Only Approved Platelet Producer in Europe Represents New Treatment Approach for Serious Chronic Autoimmune Disorder

ZUG, Switzerland, Feb. 6 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that the European Commission (EC) has granted marketing authorisation for Nplate(R) (romiplostim) for the treatment of splenectomised adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as second line treatment for adult non-splenectomised ITP patients where surgery is contra-indicated.

Nplate, the first and only approved platelet producer in Europe, has been granted marketing authorisation for the European Union (EU) based upon a positive opinion from the European Committee for Medicinal Products for Human Use in November 2008. Nplate works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.

Chronic ITP is a serious autoimmune disorder characterised by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. ITP is recognised as an orphan disease by the European Medicines Agency (EMEA) and there are an estimated 50,000 adult patients with chronic ITP in the EU.(1) Nplate is a breakthrough thrombopoiesis-stimulating peptibody that represents a new approach to the management of ITP by increasing platelet production and potentially reducing the need for rescue and other maintenance medications.

"Nplate is the first approved long-term treatment option in Europe that specifically targets platelet production," said Dr Roberto Stasi, Department of Medical Sciences, Regina Apostolorum Hospital, Italy. "Although ITP affects a limited patient population, it
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SOURCE Amgen
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