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  • Amgen Statement on Briefing Materials Prepared for March 12, 2008 ODAC Meeting

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In the News

Amgen Statement on Briefing Materials Prepared for March 12, 2008 ODAC Meeting

Briefing documents for the March 12th Oncologic Drugs Advisory Committee (ODAC) meeting regarding romiplostim are now available at www.fda.gov.

Amgen looks forward to a robust discussion with the Oncologic Drugs Advisory Committee (ODAC) on the proposed Biologic License Application (BLA) for romiplostim, an investigational thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), an orphan disease.

ITP is a serious autoimmune disorder that increases the risk of serious bleed events due to significant drops in platelet counts. Treatment of thrombocytopenia in adult patients with chronic ITP is considered an unmet need.


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