On Friday, Gilead Sciences (NASDAQ: GILD) promised to make its experimental coronavirus treatment, remdesivir, accessible to as many people as possible. Recently released clinical trial results suggest the antiviral can significantly reduce the time of recovery for hospitalized COVID-19 patients.
The Food and Drug Administration is expected to issue an emergency-use authorization for remdesivir in record time. A EUA is not the same as a formal approval for the drug as a treatment, but it will make it easier for providers to administer the antiviral to more patients.
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In a government-sponsored study, a majority of patients treated with remdesivir recovered after 11 days compared to 15 days among those given a placebo. Based on that, the wider use of remdesivir could help hospitals stretch their limited intensive-care resources significantly further.
While a EUA to treat hospitalized COVID-19 patients seems likely for remdesivir, the FDA will probably wait for results from ongoing clinical trials sponsored by Gilead Sciences before considering full approval. Gilead Sciences is running a study meant to enroll around 1,600 patients with moderate cases of COVID-19 and measure their progress after 11 days of treatment with either remdesivir or standard care.
Gilead's also enrolling an expected 6,000 patients with severe cases of COVID-19 into a study comparing remdesivir to standard care. This one will take a bit longer because investigators aren't taking measurements until day 14, but results that confirm data from the NIH trial would be worth the wait.
In the meantime, Gilead is cranking up production of remdesivir and intends to donate the first 1.5 million doses that roll off the line.
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