Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.
Identifieur interne : 000750 ( Main/Corpus ); précédent : 000749; suivant : 000751Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.
Auteurs : John G. Rizk ; Donald N. Forthal ; Kamyar Kalantar-Zadeh ; Mandeep R. Mehra ; Carl J. Lavie ; Youssef Rizk ; Joann P. Pfeiffer ; John C. LewinSource :
- Drug discovery today [ 1878-5832 ] ; 2021.
English descriptors
- KwdEn :
- Antiviral Agents (classification), Antiviral Agents (pharmacology), COVID-19 (drug therapy), COVID-19 (epidemiology), COVID-19 (prevention & control), COVID-19 Vaccines (pharmacology), Compassionate Use Trials (methods), Compassionate Use Trials (trends), Drug Approval (MeSH), Humans (MeSH), SARS-CoV-2 (MeSH), United States (MeSH).
- MESH :
- chemical , classification : Antiviral Agents.
- chemical , pharmacology : Antiviral Agents, COVID-19 Vaccines.
- geographic : United States.
- drug therapy : COVID-19.
- epidemiology : COVID-19.
- methods : Compassionate Use Trials.
- prevention & control : COVID-19.
- trends : Compassionate Use Trials.
- Drug Approval, Humans, SARS-CoV-2.
Abstract
The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been the major focus, uncertainties around new vaccine safety and effectiveness have spawned interest in other pharmacological options. Experimental drugs can also be approved under the FDA Emergency Use Authorization (EUA) program, designed to combat infectious disease and other threats. Here, we review the US experience in 2020 with pharmacological EA and EUA approvals during the pandemic. We also provide a description of, and clinical rationale for, each of the EA- or EUA-approved drugs (e.g. remdesivir, convalescent plasma, propofol 2%, hydroxychloroquine, ruxolitinib, bamlanivimab, baricitinib, casirivimab plus imdevimab) during the pandemic and concluding reflections on the EA program and its potential future uses.
DOI: 10.1016/j.drudis.2020.11.025
PubMed: 33253920
PubMed Central: PMC7694556
Links to Exploration step
pubmed:33253920Le document en format XML
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Electronic address: john.rizk@lau.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Forthal, Donald N" sort="Forthal, Donald N" uniqKey="Forthal D" first="Donald N" last="Forthal">Donald N. Forthal</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Medicine, University of California, Irvine, School of Medicine, Irvine, CA, USA; Department of Molecular Biology and Biochemistry, University of California, Irvine, School of Medicine, Irvine, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kalantar Zadeh, Kamyar" sort="Kalantar Zadeh, Kamyar" uniqKey="Kalantar Zadeh K" first="Kamyar" last="Kalantar-Zadeh">Kamyar Kalantar-Zadeh</name><affiliation><nlm:affiliation>Division of Nephrology, Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine, Irvine, CA, USA; Department of Epidemiology, University of California, Los Angeles, UCLA Fielding School of Public Health, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mehra, Mandeep R" sort="Mehra, Mandeep R" uniqKey="Mehra M" first="Mandeep R" last="Mehra">Mandeep R. Mehra</name><affiliation><nlm:affiliation>Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lavie, Carl J" sort="Lavie, Carl J" uniqKey="Lavie C" first="Carl J" last="Lavie">Carl J. Lavie</name><affiliation><nlm:affiliation>John Ochsner Heart and Vascular Institute, Ochsner Clinical School - the University of Queensland School of Medicine, New Orleans, LA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Rizk, Youssef" sort="Rizk, Youssef" uniqKey="Rizk Y" first="Youssef" last="Rizk">Youssef Rizk</name><affiliation><nlm:affiliation>Department of Family Medicine, American University of Beirut Medical Center, Beirut, Lebanon.</nlm:affiliation></affiliation></author><author><name sortKey="Pfeiffer, Joann P" sort="Pfeiffer, Joann P" uniqKey="Pfeiffer J" first="Joann P" last="Pfeiffer">Joann P. Pfeiffer</name><affiliation><nlm:affiliation>Edson College, Arizona State University, Phoenix, AZ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lewin, John C" sort="Lewin, John C" uniqKey="Lewin J" first="John C" last="Lewin">John C. Lewin</name><affiliation><nlm:affiliation>National Coalition on Health Care, Washington, DC, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Drug discovery today</title><idno type="eISSN">1878-5832</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (classification)</term><term>Antiviral Agents (pharmacology)</term><term>COVID-19 (drug therapy)</term><term>COVID-19 (epidemiology)</term><term>COVID-19 (prevention & control)</term><term>COVID-19 Vaccines (pharmacology)</term><term>Compassionate Use Trials (methods)</term><term>Compassionate Use Trials (trends)</term><term>Drug Approval (MeSH)</term><term>Humans (MeSH)</term><term>SARS-CoV-2 (MeSH)</term><term>United States (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="classification" xml:lang="en"><term>Antiviral Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Antiviral Agents</term><term>COVID-19 Vaccines</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Compassionate Use Trials</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="trends" xml:lang="en"><term>Compassionate Use Trials</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Drug Approval</term><term>Humans</term><term>SARS-CoV-2</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been the major focus, uncertainties around new vaccine safety and effectiveness have spawned interest in other pharmacological options. Experimental drugs can also be approved under the FDA Emergency Use Authorization (EUA) program, designed to combat infectious disease and other threats. Here, we review the US experience in 2020 with pharmacological EA and EUA approvals during the pandemic. We also provide a description of, and clinical rationale for, each of the EA- or EUA-approved drugs (e.g. remdesivir, convalescent plasma, propofol 2%, hydroxychloroquine, ruxolitinib, bamlanivimab, baricitinib, casirivimab plus imdevimab) during the pandemic and concluding reflections on the EA program and its potential future uses.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33253920</PMID><DateCompleted><Year>2021</Year><Month>04</Month><Day>01</Day></DateCompleted><DateRevised><Year>2021</Year><Month>04</Month><Day>01</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1878-5832</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>2</Issue><PubDate><Year>2021</Year><Month>02</Month></PubDate></JournalIssue><Title>Drug discovery today</Title><ISOAbbreviation>Drug Discov Today</ISOAbbreviation></Journal><ArticleTitle>Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.</ArticleTitle><Pagination><MedlinePgn>593-603</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1359-6446(20)30509-2</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.drudis.2020.11.025</ELocationID><Abstract><AbstractText>The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been the major focus, uncertainties around new vaccine safety and effectiveness have spawned interest in other pharmacological options. Experimental drugs can also be approved under the FDA Emergency Use Authorization (EUA) program, designed to combat infectious disease and other threats. Here, we review the US experience in 2020 with pharmacological EA and EUA approvals during the pandemic. We also provide a description of, and clinical rationale for, each of the EA- or EUA-approved drugs (e.g. remdesivir, convalescent plasma, propofol 2%, hydroxychloroquine, ruxolitinib, bamlanivimab, baricitinib, casirivimab plus imdevimab) during the pandemic and concluding reflections on the EA program and its potential future uses.</AbstractText><CopyrightInformation>Copyright © 2020 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rizk</LastName><ForeName>John G</ForeName><Initials>JG</Initials><AffiliationInfo><Affiliation>Edson College, Arizona State University, Phoenix, AZ, USA. Electronic address: john.rizk@lau.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Forthal</LastName><ForeName>Donald N</ForeName><Initials>DN</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Medicine, University of California, Irvine, School of Medicine, Irvine, CA, USA; Department of Molecular Biology and Biochemistry, University of California, Irvine, School of Medicine, Irvine, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kalantar-Zadeh</LastName><ForeName>Kamyar</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Division of Nephrology, Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine, Irvine, CA, USA; Department of Epidemiology, University of California, Los Angeles, UCLA Fielding School of Public Health, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mehra</LastName><ForeName>Mandeep R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lavie</LastName><ForeName>Carl J</ForeName><Initials>CJ</Initials><AffiliationInfo><Affiliation>John Ochsner Heart and Vascular Institute, Ochsner Clinical School - the University of Queensland School of Medicine, New Orleans, LA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rizk</LastName><ForeName>Youssef</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Family Medicine, American University of Beirut Medical Center, Beirut, Lebanon.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pfeiffer</LastName><ForeName>JoAnn P</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>Edson College, Arizona State University, Phoenix, AZ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lewin</LastName><ForeName>John C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>National Coalition on Health Care, Washington, DC, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Drug Discov Today</MedlineTA><NlmUniqueID>9604391</NlmUniqueID><ISSNLinking>1359-6446</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000086663">COVID-19 Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="Y">Antiviral Agents</DescriptorName><QualifierName UI="Q000145" MajorTopicYN="N">classification</QualifierName><QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="Y">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086663" MajorTopicYN="N">COVID-19 Vaccines</DescriptorName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057176" MajorTopicYN="Y">Compassionate Use Trials</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName><QualifierName UI="Q000639" MajorTopicYN="N">trends</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017277" MajorTopicYN="N">Drug Approval</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>10</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>11</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>11</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>12</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>4</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>11</Month><Day>30</Day><Hour>20</Hour><Minute>11</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33253920</ArticleId><ArticleId IdType="pii">S1359-6446(20)30509-2</ArticleId><ArticleId IdType="doi">10.1016/j.drudis.2020.11.025</ArticleId><ArticleId IdType="pmc">PMC7694556</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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