TY - JOUR
T1 - Medical countermeasures for unwanted CBRN exposures
T2 - Part I chemical and biological threats with review of recent countermeasure patents
AU - Singh, Vijay K.
AU - Garcia, Melissa
AU - Wise, Stephen Y.
AU - Seed, Thomas M.
N1 - Publisher Copyright:
© 2016 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2016/12/1
Y1 - 2016/12/1
N2 - Introduction: The threat of chemical, biological, radiological, and nuclear (CBRN) warfare has been addressed as the uppermost risk to national security since the terrorist attacks on 11 September 2001. Despite significant scientific advances over the past several decades toward the development of safe, non-toxic and effective countermeasures to combat CBRN threats, relatively few countermeasures have been approved by the US Food and Drug Administration (US FDA). Therefore, countermeasures capable of protecting the population from the effects of CBRN attack remain a significant unmet medical need. Chemical and biological (CB) threat agents can be particularly hazardous due to their effectiveness in small quantities and ease of distribution. Area covered: This article reviews the development of countermeasures for CB threats and highlights specific threats for which at least one countermeasure has been approved following the FDA Animal Rule. Patents of CB countermeasures since 2010 have been included. Expert opinion: Nine CB countermeasures have received FDA approval for use in humans following the Animal Rule, and a number of promising CB countermeasures are currently under development. In the next few years, we should expect to have multiple countermeasures approved by the FDA for each indication allowing for more flexible and effective treatment options.
AB - Introduction: The threat of chemical, biological, radiological, and nuclear (CBRN) warfare has been addressed as the uppermost risk to national security since the terrorist attacks on 11 September 2001. Despite significant scientific advances over the past several decades toward the development of safe, non-toxic and effective countermeasures to combat CBRN threats, relatively few countermeasures have been approved by the US Food and Drug Administration (US FDA). Therefore, countermeasures capable of protecting the population from the effects of CBRN attack remain a significant unmet medical need. Chemical and biological (CB) threat agents can be particularly hazardous due to their effectiveness in small quantities and ease of distribution. Area covered: This article reviews the development of countermeasures for CB threats and highlights specific threats for which at least one countermeasure has been approved following the FDA Animal Rule. Patents of CB countermeasures since 2010 have been included. Expert opinion: Nine CB countermeasures have received FDA approval for use in humans following the Animal Rule, and a number of promising CB countermeasures are currently under development. In the next few years, we should expect to have multiple countermeasures approved by the FDA for each indication allowing for more flexible and effective treatment options.
KW - Animal Rule
KW - chemical and biological threats
KW - countermeasures
KW - US Food and Drug Administration
UR - http://www.scopus.com/inward/record.url?scp=84996598857&partnerID=8YFLogxK
U2 - 10.1080/13543776.2017.1233178
DO - 10.1080/13543776.2017.1233178
M3 - Review article
C2 - 27599259
AN - SCOPUS:84996598857
SN - 1354-3776
VL - 26
SP - 1431
EP - 1447
JO - Expert Opinion on Therapeutic Patents
JF - Expert Opinion on Therapeutic Patents
IS - 12
ER -