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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

own immune system. Low platelet counts leave adult ITP patients open to sudden serious bleeding events. The risk for serious bleeding events increases when platelet counts drop to less than 30,000 platelets per microliter; normal counts range from 150,000 to 400,000 platelets per microliter. ITP has historically been considered a disease of platelet destruction although recent data suggest that the body's natural platelet production processes in ITP are unable to compensate for low levels of platelets in the blood. Increasing the rate of platelet production may address low platelet levels associated with ITP.

Currently available treatments (i.e., corticosteroids, immunoglobulins) have limited application due to poor tolerability or transient effects. Surgical therapy (removal of the spleen) is also available to adult patients with chronic ITP, but does not work in all cases. Currently, there are 140,000 treated chronic ITP patients in Europe and the U.S. ITP affects about twice as many adult women as men.

About Nplate

Nplate was granted approval for ITP by the regulatory bodies in Australia in July and the United States (U.S.) in August 2008. Amgen has filed for regulatory approval of Nplate in Canada and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the U.S. (2003), the EU (2005), Switzerland (2005) and Japan (2006).

Nplate is the first treatment specifically developed for ITP. It is also being investigated for potential use in paediatric ITP, myelodysplastic syndromes (MDS) and chemotherapy-induced thrombocytopenia (CIT).

Important EU Nplate Safety Information

The most common side effects are headache, fatigue, arthralgia, myalgia, injection site bruising, injection site pain, peripheral oedema, dizziness, muscle spasms, nausea, contusion, diarrhoea, bone marrow disorder, influenza like il
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SOURCE Amgen
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