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

ed to determine the precise role of Nplate in the development of the adverse events. Based in part on this determination, and the data submitted from clinical trials, the FDA and Amgen have concluded that the restricted elements of the REMS can be eliminated. For this reason enrollment of prescribers, patients and institutions and mandatory collection of safety data is no longer required. 

As of Dec. 7, 2011, prescribing physicians and institutions will be able to order Nplate without enrolling themselves or patients in the Nplate® NEXUS Program. The program will continue to obtain information from already enrolled patients through Jan. 5, 2012, and Nplate® NEXUS Program support assistance will continue for 28 days after approval of the modified REMS.

About Adult ITP

In patients with immune thrombocytopenia (ITP), platelets - blood elements 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. 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 also 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, there are approximately 90,000 adult chronic ITP patients in Europe and the U.S. ITP affects about twice as many adult women as men.

The Nplate FIRST STEP™ Co-Pay Coupon Card Program

Last year, Amgen announced its co-pay coupon umbrella program, the Amgen FIRST STEP™ Program, for commercially insured patients. As part of that program, the Nplate FIRST STEPT
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