The ‘very, very bad look' of remdesivir, the first FDA-approved COVID-19 drug

The ‘very, very bad look' of remdesivir, the first FDA-approved COVID-19 drug

Cohen et al., Science, doi:10.1126/science.abf4549, Oct 2020

Discussion of the controversial approval of remdesivir as the first FDA-approved drug for COVID-19 treatment in October 2020. Despite mixed results from clinical trials, including the large WHO Solidarity study that showed no significant benefits, the FDA approved remdesivir without consulting the external advisory committee. The European Union also agreed to a billion-dollar deal with the drug's manufacturer just before the disappointing WHO trial results were released, while the results were known to the manufacturer. Authors highlight concerns about the FDA's decision-making process, Gilead's aggressive marketing despite questionable efficacy, and the lack of transparency in both the FDA approval and EU procurement. Critics argue that the available data did not support such a strong endorsement of remdesivir, and that public discussion of the evidence would have been beneficial.

Reviews covering remdesivir for COVID-19 include1-5.

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1. Shen et al., Carboxylesterase Factors Influencing the Therapeutic Activity of Common Antiviral Medications Used for SARS-CoV-2 Infection, Pharmaceutics, doi:10.3390/pharmaceutics17070832.mdpi.com, doi.org.

2. Vukovikj et al., Impact of SARS-CoV-2 variant mutations on susceptibility to monoclonal antibodies and antiviral drugs: a non-systematic review, April 2022 to October 2024, Eurosurveillance, doi:10.2807/1560-7917.ES.2025.30.10.2400252.eurosurveillance.org, doi.org.

3. Saha et al., Inhaled Dry Powder of Antiviral Agents: A Promising Approach to Treating Respiratory Viral Pathogens, Viruses, doi:10.3390/v17020252.mdpi.com, doi.org.

4. Lopez et al., SARS-CoV-2 Resistance to Small Molecule Inhibitors, Current Clinical Microbiology Reports, doi:10.1007/s40588-024-00229-6.springer.com, doi.org.

5. Bacigalupo et al., Unveiling patenting strategies of therapeutics and vaccines: evergreening in the context of COVID-19 pandemic, Frontiers in Medicine, doi:10.3389/fmed.2023.1287542.frontiersin.org, doi.org.

Cohen et al., 28 Oct 2020, preprint, 2 authors.

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