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

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In the EU, Nplate is indicated for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins). Nplate may be considered as a second-line treatment for adult non-splenectomized ITP patients for whom surgery is contraindicated.

Nplate was named as a recipient of the U.S. Prix Galien 2009 "Best Biotechnology Product" award and also received the 2009 Scrip Awards for "Best New Drug." Nplate has also been honored with numerous awards throughout the EU, including a 2010 Prix Galien in France in the category of "Drugs for Rare Diseases," and the 2011 Prix Galien in Germany in the category of "Specialist Care." In September 2010, Nplate was awarded the 2010 International Prix Galien Award, an award granted every two years which recognizes the "best of the best" selected from previous national Prix Galien award recipients.

For more information about Nplate, please visit www.Nplate.com.

Important U.S. Nplate Safety Information

The risks associated with Nplate include progression of MDS to acute myelogenous leukemia (AML) in patients with MDS, thrombotic/thromboembolic complications, bone marrow reticulin formation and risk for bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, and lack or loss of response to Nplate.  In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.

Important EU Nplate Safety Information

The most common side effects are headache, fatigue, arthralgia and myalgia.

The risks associated with Nplate include reoccurrence of thrombocytopenia, bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, progression of existing MDS (in patients with MDS), loss of response to Nplate, and effects on red and white blood cells.

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