Promising results from clinical trials of convalescent plasma, 3 monoclonal antibodies, or other experimental drugs will put pressure on the FDA to emergently authorize use in the face of incomplete knowledge about efficacy and insufficient supply. These problems are not specific to remdesivir or to the current pandemic: governments and health systems will predictably encounter situations during pandemics in which novel therapeutics are in short supply and knowledge about their harms and benefits is limited. 2 Second, there remain major gaps in knowledge about the efficacy of remdesivir, including whether it reduces mortality and what subgroups of patients may benefit the most. First, the supply of remdesivir is insufficient to treat all eligible patients, which has required hospitals to ration the drug. However, the US and other countries have 2 major problems related to this drug. 1 Anticipating immediate worldwide demand, the maker of remdesivir, Gilead Sciences, donated 1.5 million doses of remdesivir to countries affected by the pandemic, including the US, which received 607 000 doses (enough to treat approximately 100 000 patients).
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The authorization was based on a preliminary report from a randomized clinical trial in 1063 patients that found that remdesivir shortened the median time to recovery from 15 days to 11 days. On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the unapproved drug remdesivir to treat hospitalized patients with severe coronavirus disease 2019 (COVID-19).