Remdesivir Approved for Treatment of COVID-19

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The U.S. Food and Drug Administration (FDA) just approved the first drug for the treatment of COVID-19 – the antiviral drug Remdesivir.

Remdesivir is an antiviral drug, originally developed to treat Hepatitis C and Ebola. However, when tested on animal models, the drug showed effectiveness against both SARS (severe acute respiratory syndrome) coronavirus and MERS (Middle East respiratory syndrome) coronavirus. 

This led doctors to consider the drug for the treatment of COVID-19.

On 1st May, the FDA authorized the use of Remdesivir for the treatment of COVID-19 under an Emergency Use Authorization (EUA).  The EUA allows the usage of unapproved drugs in cases of medical emergencies such as pandemics, to prevent severe complications and fatalities. Especially, when no other adequate alternatives are available. 

Remdesivir Receives FDA’S Approval

On 22nd October ’20, FDA approved Remdesivir for the treatment of COVID-19. The drug was approved for use in adults, children 12 years of age or older and, those weighing 40 kilograms or more. Furthermore, patients younger than 12 years of age or weighing under 40 kilograms can still receive the drug under EUA.

Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.

Stephen M. Hahn, M.D (FDA Commissioner)

The decision was made after reviewing multiple clinical trials carried out in the past. These clinical trials investigated the effect of Remdesivir in patients hospitalized with mild to severe COVID-19. The findings of the studies showed a shorter hospital stay among patients treated with the antiviral drug.

WHO’s trial Finds the Drug Ineffective

FDA’s approval comes despite a recent trial by the World Health Organization (WHO) stating the antiviral drug as ineffective in improving the outcome of hospitalized patients. 

WHO’s trial included patients from across 30 countries. The 11, 200 patients received treatment with remdesivir, hydroxychloroquine, Interferon-β1a, lopinavir or did not receive any treatment at all. Results showed no single drug or drug combination reduced deaths among the patients, as compared to the no-drug group. 

However, the trial has come under critique for not being a ‘blinded’ trial along with many other limitations. Moreover, the study has yet to be peer-reviewed.

While the approval of Remdesivir is definitely a big step forward, it is important to remember that the drug is not a cure for the disease. According to Dr. Peter Lurie, a former associate commissioner with the F.D.A,

This is not some massive breakthrough. It’s a drug that appears convincingly to benefit patients, but it’s not some kind of miracle cure.

Dr. Peter Lurie

Reference:

Commissioner, O. (2020, October 22). FDA Approves First Treatment for COVID-19. Retrieved October 25, 2020, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

Pan, Hongchao, et al. “Repurposed Antiviral Drugs for COVID-19 –Interim WHO SOLIDARITY Trial Results.” 2020, doi:10.1101/2020.10.15.20209817

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