Amgen’s investigative agent Nplate is set to be reviewed by the United States Food and Drug Administration’s (FDAs) Oncologic Drugs Advisory Committee (ODAC) on March 12, 2008.
The biologics license application (BLA) for Nplate was submitted by Amgen October 2007, obtaining priority review status. The proposed indication for Nplate is for the treatment of chronic idiopathic thrombocytopenia purpura (ITP) in adults who have not responded to corticosteroids or immunoglobulins prior to spleen removal, or who are intolerant to these therapeutic approaches.
Amgen estimates that 60,000 patients could potentially benefit from treatment with Nplate.
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