title: Development and licensure of medical countermeasures to treat lung damage resulting from a radiological or nuclear incident.
abstract: Due to the ever-present threat of a radiological or nuclear accident or attack, the National Institute of Allergy and Infectious Diseases, Radiation Medical Countermeasures Program was initiated in 2004. Since that time, the Program has funded research to establish small and large animal models for radiation damage, as well as the development of approaches to mitigate/treat normal tissue damage following radiation exposure. Because some of these exposures may be high-dose, and yet heterogeneous, the expectation is that some victims will survive initial acute radiation syndromes (e.g. hematopoietic and gastrointestinal), but then suffer from potentially lethal lung complications. For this reason, efforts have concentrated on the development of animal models of lung irradiation damage that mimic expected exposure scenarios, as well as drugs to treat radiation-induced late lung sequelae including pneumonitis and fibrosis. Approaches targeting several pathways are under study, with the eventual goal of licensure by the United States Food and Drug Administration for government stockpiling. This Commentary outlines the status of countermeasure development in this area and provides information on the specifics of licensure requirements, as well as guidance and a discussion of challenges involved in developing and licensing drugs and treatments specific to a radiation lung damage indication.
authors.affiliation: Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA. cohena@niaid.nih.gov
authors.forename: Andrea L
authors.initials: AL
authors.lastname: DiCarlo
authors.forename: Isabel L
authors.initials: IL
authors.lastname: Jackson
authors.forename: Jui R
authors.initials: JR
authors.lastname: Shah
authors.forename: Christine W
authors.initials: CW
authors.lastname: Czarniecki
authors.forename: Bert W
authors.initials: BW
authors.lastname: Maidment
authors.forename: Jacqueline P
authors.initials: JP
authors.lastname: Williams
mesh_terms: D054508:Acute Radiation Syndrome / Q000150:complications / Q000188:drug therapy; D032761:Animal Experimentation / Q000331:legislation & jurisprudence; D000818:Animals; D015415:Biomarkers; D006801:Humans; D008004:Licensure; D008168:Lung / Q000528:radiation effects*; D008171:Lung Diseases / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D023421:Models, Animal; D054579:National Institute of Allergy and Infectious Diseases (U.S.); D009689:Nuclear Warfare; D011658:Pulmonary Fibrosis / Q000209:etiology / Q000517:prevention & control; D011833:Radiation Injuries, Experimental / Q000188:drug therapy / Q000517:prevention & control; D017564:Radiation Pneumonitis / Q000188:drug therapy / Q000517:prevention & control; D011836:Radiation Tolerance; D011837:Radiation-Protective Agents / Q000600:supply & distribution / Q000627:therapeutic use*; D011847:Radioactive Fallout / Q000009:adverse effects; D018788:Radioactive Hazard Release; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D011837:Radiation-Protective Agents; D011847:Radioactive Fallout