BioPharma

Landmark FDA approval of antiviral drug as 1st COVID-19 treatment comes amid conflicting efficacy data

The Food and Drug Administration approved Gilead's antiviral drug as the first treatment for Covid-19 but just last week a WHO report showed that the drug appeared to have little to no effect on hospitalized patients.

By Anuja Vaidya on October 22, 2020

Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

The FDA has approved remdesivir for the treatment of Covid-19, making it the first and only treatment for the disease caused by the new coronavirus. The green light from the agency comes just one week after a WHO report found that the drug wasn’t that effective in patients hospitalized with the illness.

Manufactured by Gilead Sciences, the antiviral medication had earlier received emergency use authorization by the FDA for Covid-19 treatment in May and has since been available in hospitals around the country. In fact, President Donald Trump was given remdesivir when he contracted Covid-19 earlier this month.

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The drug works to prevent the coronavirus from replicating and is sold under brand name Veklury. It can be used to treat adults and children, older than 12 years, who have contracted Covid-19 and are hospitalized.

“In less than one year, the world has moved from a sense of desperation to understand an unknown disease spreading all too quickly and taking lives, to one of hope that we now have enough knowledge and a growing set of tools to help fight COVID-19,” wrote Dr. Merdad Parsey, chief medical officer of Gilead Sciences, in an open letter provided to MedCity News.

The FDA approved the drug based on results from three randomized controlled trials including one conducted by the National Institute of Allergy and Infectious Diseases. The study, published in The New England Journal of Medicine, showed that remdesivir “was superior to placebo” in reducing the amount of time hospitalized adults took to recover from Covid-19. Study participants who received remdesivir had a median recovery time of 10 days, as compared to 15 days among those who received placebo. But the study also shows that serious adverse events were reported in 131 of the 532 patients who received remdesivir.

Meanwhile, a preliminary report published just last week from the World Health Organization based on data from over 400 hospitals in 30 countries concluded that remdesivir “appeared to have little or no effect” on those hospitalized with Covid-19.

Though there is no overwhelming evidence of the drug’s efficacy against Covid-19, Gilead Sciences is charging $3,120 per course of treatment, The Washington Post reported. A Credit Suisse investment analyst estimates that the company will rake in more than $9 billion from the drug in 2020 and 2021.

Meanwhile, doctors on Twitter last week were weighing in on contrary signals about remdesivir given the WHO Solidarity trial data.

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Photo: Waldemarus, Getty Images