Remdesivir: The First and Only FDA Approved Drug for COVID-19 Treatment

Written by Josephine Chen '24
Edited by Jacqueline Cho '24

On October 22, 2020, antiviral drug Veklury, or more commonly known as remdesivir, became the first and only treatment approved by the U.S. Food and Drug Administration (FDA) to be used on COVID-19 patients [1]. The drug was first issued an Emergency Use Authorization (EUA) in May, but now with considerable evidence supporting the drug’s effectiveness in numerous trials, the FDA has deemed the drug to be beneficial and safe for universal patient treatment [1]. 

COVID-19 is an infectious disease caused by the coronavirus SARS-CoV-2. The genetic material of the virus is located in the RNA. Our cells incorrectly identify the coronavirus RNA as those produced by our cells’ healthy DNA. Thus, our cells read and replicate the virus RNA, producing proteins that harm our bodies [2]. The virus then spreads throughout the body, causing risk of potential spread to other people in the form of water droplets from our saliva, sweat, etc [2]. Therefore, the primary method remdesivir can combat the coronavirus is by targeting the virus RNA. 

Remdesivir is an antiviral drug, which is a class of medication that impedes the growth and replication of pathogens, or disease causing microorganisms. Antiviral drugs are different from antibiotics: they inhibit rather than kill their target pathogens. Specifically, remdesivir slows the replication of the virus RNA by binding to the RNA polymerase, which is an enzyme that copies genetic information from DNA to form RNA. The treatment is given in the form of an injection. 

To test for the treatment’s effectiveness and safety on patients, a double-blind, randomized study was performed by the National Institute of Allergy and Infectious Diseases (NIH). Out of 1062 patients with moderate to severe cases of COVID-19, 541 patients were randomly selected to receive the remdesivir treatment, while 521 patients were given a placebo treatment [3]. Neither group knew the treatment that they were receiving. Patients were considered to be recovered when they no longer required supplemental oxygen and medical care. 

Patients who received remdesivir were able to recover faster than those who received the placebo treatment. With the trial set for 29 days, the median recovery time was 10 days for the remdesivir group and 15 days for the placebo group [3]. For patients with severe cases of COVID-19, the median recovery time for the remdesivir group was 11 days, while the time for the placebo group was 18 days [3]. By the last day, the estimated mortality rate was 11.4% for the remdesivir group and 15.2% for the placebo group [3].

Despite the positive results presented by the study, there were several harmful occurrences that took place during the trials, including but not limited to respiratory failure, anemia, and increased blood glucose levels [3]. However, in all events, there were less patients in the remdesivir group who were affected in comparison to the placebo group. For instance, eighty patients who received the placebo treatment had respiratory failure during their hospitalization, while only 47 patients who received remdesivir had the same problem [3]. 

Due to limited information, the FDA has placed limitations on treatment usage. Remdesivir can only be administered to patients who are at least 12 years old and weigh at least 40 kilograms. In addition, the drug can only be used in a healthcare setting. Research on the drug’s effect on the pediatric population is still being conducted to ensure the safety of these patients. 

There are several side effects correlated with the use of remdesivir that should be noted. Remdesivir has shown to cause hepatotoxicity, which is liver damage caused by chemical toxicity [4]. This type of liver damage is most commonly associated with medicine use. The drug has caused gastrointestinal symptoms, which included vomiting and nausea [4]. Another consequence of using the drug is respiratory failure, as shown in the recent study conducted by the NIH [4]. This is caused by low oxygen levels in the blood. The treatment is also toxic to the cardiovascular system, which was demonstrated by a cardiac arrest case in a study in China [4]. There has been evidence that remdesivir causes nephrotoxicity, leading to acute kidney injury and renal failure [4, 5]. Other studies have shown that the drug also causes reproductive toxicity. Usage of the treatment has been associated with multiple-organ-dysfunction syndrome, rash, septic shock, and more [4, 5] . Nonetheless, some of these studies have only been performed on animals, and cannot be connected to humans with certainty. More studies need to be conducted for conclusive results.

Overall, results indicate that remdesivir improves the recovery time and process for patients with the coronavirus. Remdesivir has also been shown to prevent more serious respiratory disorders, as remdesivir patients did not need as much extra oxygen as the placebo patients did. With less ventilation and oxygen necessary for remdesivir patients, there would be less hospital supplies used, which is especially important during the pandemic [3]. However, even with the remdesivir treatment, there were high mortality rates. It can be concluded that additional treatment along with remdesivir is necessary for many patients. It is important that more research is done to better understand the treatment and its effects when used simultaneously with other drugs. For everyone’s safety for the time being, it is best to wear a mask when outside and socially distance from groups of people. 

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Works Cited: 

[1] Commissioner Of the FDA Approves First Treatment for COVID-19 [Internet]. U.S. Food and Drug Administration. FDA; 2020 [cited 2020Oct28]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 

[2] Gandhi RT, Lynch JB, del Rio C. Mild or Moderate Covid-19: NEJM [Internet]. New England Journal of Medicine. 2020 [cited 2020Oct28]. Available from: https://www.nejm.org/doi/full/10.1056/NEJMcp2009249 

[3] Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the Treatment of Covid-19 — Final Report. N Engl J Med [Internet]. 2020 May 22 [cited 2020 Oct 28]; Available from: https://doi.org/10.1056/NEJMoa2007764

[4] Fan Q, Zhang B, Ma J, Zhang S. Safety profile of the antiviral drug remdesivir: An update [Internet]. Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. The Author(s). Published by Elsevier Masson SAS.; 2020 [cited 2020Oct28]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373689/ 

[5] Grein J, Ohmagari N, Shin D, Dias G, Asperges E, Castagna A. Compassionate Use of Remdesivir for Patients with Severe Covid-19: NEJM [Internet]. New England Journal of Medicine. 2020 [cited 2020Oct28]. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2007016 
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[Image Citation] Liu A. [Internet]. Marketing COVID-19 fighter remdesivir racks up $873M as Gilead plays defense on unflattering WHO data. 2020 [cited 2020Nov8]. Available from: https://www.fiercepharma.com/marketing/remdesivir-sales-hit-873m-as-gilead-gets-defensive-against-who-data-covid-19-drug 

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