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Amgen and FDA Agree to Modify Nplate® (Romiplostim) Risk Evaluation and Mitigation Strategy
Date:12/6/2011

82; Co-Pay Coupon Card Program, is intended to provide assistance to eligible patients who need help meeting their Nplate deductible, co-insurance and/or co-payment (out-of-pocket) requirements. The Amgen FIRST STEP™ Program is significant among oncology commercial co-pay coupon programs, as it is the first program under the medical benefit with no income eligibility requirement. Under this program, eligible patients will incur no out of pocket costs for their first Nplate treatment associated with a new treatment regimen and will pay a maximum of $25 for subsequent injections. More information, eligibility requirements, restrictions and limitations about the co-pay coupon program are available at www.AmgenFIRSTSTEP.com.

About Nplate

Nplate is approved in the U.S., European Union (EU), Canada, Australia, Russia, Mexico, Switzerland, Lichtenstein, Japan, Argentina, Israel, South Korea, Hong Kong, and Chile. Nplate also has received orphan designation for chronic ITP in the U.S. (2003), the EU (2005), Switzerland (2005), Japan (2006), Mexico (2010) and South Korea (2010).

Nplate is the first FDA-approved treatment specifically for adult chronic ITP. It is also being investigated for potential use in children ages 12 months to 18 years old with persistent severe thrombocytopenia, and chemotherapy-induced thrombocytopenia (CIT).

In the U.S., Nplate is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP.  Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet count
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