Medical countermeasures for unwanted CBRN exposures: part II radiological and nuclear threats with review of recent countermeasure patents.
The global threat of a chemical, biological, radiological, or nuclear (CBRN) disaster is an important priority for all government agencies involved in domestic security and public health preparedness. Radiological/nuclear (RN) attacks or accidents have become a larger focus of the United States Food and Drug administration (US FDA) over time because of their increased likeliness. Clinical signs and symptoms of a developing acute radiation syndrome (ARS) are grouped into three sub-syndromes named for the dominant organ system affected, namely the hematopoietic (H-ARS), gastrointestinal (GI-ARS), and neurovascular systems. The availability of safe and effective countermeasures against radiological/nuclear threats currently represents a significant unmet medical need. Areas covered: This article reviews the development of RN threat medical countermeasures and highlights those specific countermeasures that have been recently patented and approved following the FDA Animal Rule. Patents for such agents from 2015 have been presented. Expert opinion: Two granulocyte colony-stimulating factor (G-CSF)-based radiation countermeasures (Neupogen® (Amgen, Thousand Oaks, CA) and Neulasta® (Amgen, Thousand Oaks, CA)) have recently been approved by the FDA for treatment of H-ARS and both these agents are radiomitigators, used after radiation exposure. To date, there are no FDA-approved radioprotectors for ARS.
a Department of Pharmacology and Molecular Therapeutics , F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences , Bethesda , MD , USA.|b Armed Forces Radiobiology Research Institute , Uniformed Services University of the Health Sciences , Bethesda , MD , USA.
Vijay K
VK
Singh
b Armed Forces Radiobiology Research Institute , Uniformed Services University of the Health Sciences , Bethesda , MD , USA.
Patricia L P
PL
Romaine
b Armed Forces Radiobiology Research Institute , Uniformed Services University of the Health Sciences , Bethesda , MD , USA.
Victoria L
VL
Newman
c Tech Micro Services , Bethesda , MD , USA.
Thomas M
TM
Seed
D054508:Acute Radiation Syndrome / Q000517:prevention & control*; D000818:Animals; D004189:Disaster Planning / Q000379:methods*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D010330:Patents as Topic; D011837:Radiation-Protective Agents / Q000494:pharmacology* / Q000627:therapeutic use; D018788:Radioactive Hazard Release; D023481:Terrorism; D014481:United States; D014486:United States Food and Drug Administration
D011837:Radiation-Protective Agents; D016179:Granulocyte Colony-Stimulating Factor
Animal Rule; countermeasures; food and drug administration; radiological and nuclear threats