FDA Approves Nplate ® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia

Application Granted Priority Review Designation Approval Based on Results That Demonstrated Nplate Successfully Increased and Sustained Platelet Counts in Children Affected by Rare Blood Disorder THOUSAND OAKS, Calif., Dec. 14, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate┬« (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. "Today's approval underscores our long-standing co...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news