Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic
Copyright © 2020 Elsevier Ltd. All rights reserved..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
|---|---|
| Enthalten in: |
Drug discovery today - 26(2021), 2 vom: 01. Feb., Seite 593-603 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Rizk, John G [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Completed 01.04.2021 Date Revised 07.12.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.drudis.2020.11.025 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM318202913 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM318202913 | ||
| 003 | DE-627 | ||
| 005 | 20231225164848.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.drudis.2020.11.025 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1060.xml |
| 035 | |a (DE-627)NLM318202913 | ||
| 035 | |a (NLM)33253920 | ||
| 035 | |a (PII)S1359-6446(20)30509-2 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Rizk, John G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 01.04.2021 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Elsevier Ltd. All rights reserved. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 700 | 1 | |a Forthal, Donald N |e verfasserin |4 aut | |
| 700 | 1 | |a Kalantar-Zadeh, Kamyar |e verfasserin |4 aut | |
| 700 | 1 | |a Mehra, Mandeep R |e verfasserin |4 aut | |
| 700 | 1 | |a Lavie, Carl J |e verfasserin |4 aut | |
| 700 | 1 | |a Rizk, Youssef |e verfasserin |4 aut | |
| 700 | 1 | |a Pfeiffer, JoAnn P |e verfasserin |4 aut | |
| 700 | 1 | |a Lewin, John C |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Drug discovery today |d 1998 |g 26(2021), 2 vom: 01. Feb., Seite 593-603 |w (DE-627)NLM095449159 |x 1878-5832 |7 nnns |
| 773 | 1 | 8 | |g volume:26 |g year:2021 |g number:2 |g day:01 |g month:02 |g pages:593-603 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.drudis.2020.11.025 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 26 |j 2021 |e 2 |b 01 |c 02 |h 593-603 | ||