Therapeutic for treatment of Thrombocytopenia arising from H-ARS

Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to procure a U.S. Food and Drug Administration (FDA) approved thrombopoietin receptor agonist, for use as a MCM that can treat thrombocytopenia arising as a pathology of acute exposure to ionizing radiation that may be a consequence of a radiological/nuclear mass casualty event . The procured therapeutic will be delivered to the ASPR/Strategic National Stockpile and maintained as vendor managed inventory. The USG seeks therapeutics that meet the following mandatory  criteria: 1) The approved label indication shall be to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation H-ARS and 2) The approved label shall state the drug’s mechanism of action is through stimulation of thrombopoiesis and/or treatment of thrombocytopenia resulting in a statistically significant increase in platelet counts and 3) The MCM is effective when administered at 24-hours or more post-radiation exposure.