Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.
Drug Discov Today
; 26(2): 593-603, 2021 02.
Article
in English
| MEDLINE | ID: covidwho-1065014
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Antiviral Agents
/
Compassionate Use Trials
/
COVID-19 Vaccines
/
COVID-19
/
COVID-19 Drug Treatment
Type of study:
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Drug Discov Today
Journal subject:
Pharmacology
/
Drug Therapy
Year:
2021
Document Type:
Article
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