Amgen's Nplate (Romiplostim) Receives FDA's Approval for Immune Thrombocytopenia Aged 1 year and Older
Shots:
- The approval is based on P-III & P-I/II study results assessing Nplate vs PBO in pediatric patients with Immune Thrombocytopenia (ITP) for at least six months who had no response to corticosteroids- immunoglobulins or splenectomy
- The P-III & P-I/II study demonstrated increase in overall platelet response (71% vs 20%) with durable platelet response (52% vs 10%)
- Nplate is a thrombopoietin (TPO) receptor agonist approved in 67 countries including the US and EU for increase in platelet count for patients with ITP
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