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Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union
Date:11/21/2008

ups when treated with Nplate. Additionally, patients treated with Nplate were able to reduce or discontinue concomitant ITP and emergency medications which are often not well tolerated or whose effects are transient (i.e. corticosteroids, IVIG, Win-Rho Anti-D therapy).

Upon completion of the Phase 3 studies almost 90 percent of patients elected to subsequently enroll into the romiplostim long term extension study which demonstrated that, after three years, Nplate continued to effectively increase and sustain platelet counts. In this open label long term extension study some patients were treated for over 156 weeks and in the interim analysis the median treatment duration in this study is 65 weeks.

About Adult ITP

In patients with ITP, platelets -- or blood cells needed to prevent bleeding -- are destroyed by the patient's own immune system. Low platelet counts leave adult ITP patients open to sudden serious bleeding events, making it impossible to arrest blood flow. 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.

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SOURCE Amgen
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