Key Takeaways

The Food and Drug Administration (FDA) approved Veklury (remdesivir) for the treatment of COVID-19 in hospitalized patients 12 and older on Thursday. This is the first officially FDA-approved drug for COVID-19.

Although the drug is now approved, the approval does not extend to all groups. Patients must weigh at least 40 kilograms (kg)—about 88 pounds—to receive remdesivir. In an effort to continue to offer the drug to pediatric patients covered under the first EUA when necessary, the FDA has reissuedanotherEUA for remdesiver use in:

What Is Remdesivir?Remdesivir is a direct acting antiviral drug that inhibits viral ribonucleic acid (RNA) synthesis. Coronaviruses, including SARS-CoV-2, are a family of single-stranded RNA genome. Remdesivir has been proven to stop these viruses from replicating.

What Is Remdesivir?

Remdesivir is a direct acting antiviral drug that inhibits viral ribonucleic acid (RNA) synthesis. Coronaviruses, including SARS-CoV-2, are a family of single-stranded RNA genome. Remdesivir has been proven to stop these viruses from replicating.

Remdesivir and COVID-19

Remdesivir first made headlines in the spring when Texas researchers identified the intravenous drug as “the most promising therapy” for COVID-19 despite limited clinical data.

When SARS-CoV-2 emerged, researchers saw promising results after testing remdesivir on the virus in a lab, and clinical trials began shortly thereafter, explainsMatthew D. Hall, PhD, who works at the National Center for Advancing Translational Sciences at the National Institutes of Health. He helped make the COVID-19OpenData Portalto share COVID-19-related drug repurposing data and experiments for all approved drugs.

“Most approved drugs take 15 years and a couple billion dollars to develop on average,” Hall tells Verywell. “But we didn’t have 15 years; we didn’t even have 15 weeks.”

Hall says he and his team were tasked with evaluating existing resources.

“We needed to look around for the things that were already available to us that either were approved to treat other illnesses or were being developed to treat other illnesses,” he says. “They might not be approved yet, but hopefully they’ve been in humans and we know they’re safe. We’re lucky enough to have lots of antiviral drugs. Of those drugs that are approved, or drug candidates, remdesivir appears to have been the most active, which is why it could be moved to clinical trials really quickly.”

Matthew D. Hall, PhDMost approved drugs take 15 years and a couple billion dollars to develop on average. But we didn’t have 15 years; we didn’t even have 15 weeks.

Matthew D. Hall, PhD

Most approved drugs take 15 years and a couple billion dollars to develop on average. But we didn’t have 15 years; we didn’t even have 15 weeks.

The FDA initially granted an EUA on May 1 to allow hospitalized adult patients with severe COVID-19 to be treated with remdesivir. A person with severe COVID-19 was defined as:

The expanded EUA helped make the drug available to patients at earlier stages or with milder cases of the disease, and the approval should only increase its availability. Hall says patients don’t need to be registered as part of a clinical trail to receive treatment, increasing access to people living in rural communities who do not live near research facilities.

Development of RemdesivirRemdesivir was initially developed as part of a collaboration between Gilead Sciences, the U.S. Centers for Disease Control and Prevention and the U.S. Army Medical Research Institute of Infectious Diseases. It was explored as a potential therapeutic during the West African Ebola virus epidemic and for two other coronaviruses: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

Development of Remdesivir

Remdesivir was initially developed as part of a collaboration between Gilead Sciences, the U.S. Centers for Disease Control and Prevention and the U.S. Army Medical Research Institute of Infectious Diseases. It was explored as a potential therapeutic during the West African Ebola virus epidemic and for two other coronaviruses: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

Who Should Take Remdesivir?

Remdesivir’s optimal patient population, dosing, and duration of treatment are not known. In a fact sheet for healthcare providers, the FDA offers the following recommendations:

Gilead Sciences is working to scale up production and distribution of remdesivir, which is considered an investigational drug and is not currently approved for any indication.

COVID-19 Treatments: What You Need to Know

Clinical Trials and Preliminary Findings

The FDA’s decision to approve remdesivir is based on research findings from a few clinical trials, and has been met with mixed opinions from the medical community.

“What I think about any drug or any drug candidate doesn’t really matter,” Hall says. “What really matters is data from a well-controlled clinical trial. The FDA wouldn’t have widened the scope of the EUA if they didn’t think it there would be benefit for more patients.”

In a study published April 29 inThe Lancet,a group of physicians and researchers conducted a randomized, double-blind, placebo-controlled trial of 237 adult patients with severe COVID-19 at 10 hospitals in Hubei, China.They found remdesivir helped speed recovery.

“Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less,” the authors write.

A U.S. government-sponsored study published its preliminary findings on May 22 in theNew England Journal of Medicinefrom a randomized, double-blind placebo-controlled trial of 1,063 COVID-19 patients. Researchers found that those assigned a 10-day course of remdesivir had a shorter recovery time compared to placebo—a median of 11 vs. 15 days.

“These preliminary findings support the use of remdesivir for patients who are hospitalized with COVID-19 and require supplemental oxygen therapy,” the authors write. “However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”

On August 21, theJournal of the American Medical Associationpublished a randomized phase-3 trial of 584 patients hospitalized with moderate COVID-19 pneumonia.Remdesivir manufacturer Gilead Sciences sponsored this trial in 105 hospitals in the United States, Europe, and Asia. Patients received either a 5-day or 10-day course of remdesivir or were given standard care. Researchers found no difference in outcomes among the 10-day group, and little meaningful difference among the 5-day group.

Why Developing a COVID-19 Vaccine Is So Challenging

All three studies faced different limitations and had important design differences, so it’s not fair to create an apples to apples comparison. However, it does raise questions about replicating findings, a hallmark of clinical research.

“There are now three [randomized control trials] of remdesivir in hospitalized patients with differing results, raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” University of Pittsburgh School of Medicine researchers wrote in an editorial published in theJournal of the American Medical Associationon August 21.“It therefore seems prudent to urgently conduct further evaluations of remdesivir in large-scale randomized control trials designed to address the residual uncertainties and inform optimal use.”

What This Means For YouThe U.S. Food and Drug Administration has granted its first COVID-19 treatment approval to remdesivir. If you are hospitalized with a confirmed or suspected case of COVID-19, your healthcare provider may decide to prescribe this drug.

What This Means For You

The U.S. Food and Drug Administration has granted its first COVID-19 treatment approval to remdesivir. If you are hospitalized with a confirmed or suspected case of COVID-19, your healthcare provider may decide to prescribe this drug.

What’s Next for Remdesivir?

More clinical trials are underway, according to the Gilead Scienceswebsite. The company is also in thefirst phase of developmentto formulate remdesivir as an inhaler.

“With remdesivir, we’re super lucky it existed,” Hall says. “We’re lucky it was being developed for Ebola. We’re lucky that it was available to be tested in humans now. Because if you subtract remdesivir from the equation, I don’t know what the next best thing is. There’s no other drug approved for treating SARS-CoV-2 infection.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

10 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food and Drug Administration.FDA Approves First Treatment for COVID-19.

Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, et al.Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.The Lancet.2020 May;395(10236):1569-1578. doi:10.1016/S0140-6736(20)31022-9

Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB.Pharmacologic treatments for coronavirus disease 2019 (COVID-19): A review.JAMA.2020;323(18):1824–1836. doi:10.1001/jama.2020.6019

Food and Drug Administration.Letter to Gilead Sciences.

Beigel BH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, et al.Remdesivir for the treatment of COVID-19 — Preliminary report.NEJM. doi:10.1056/NEJMoa2007764

Spinner CD, Gottlieb RL, Criner GJ, et al.Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: A randomized clinical trial.JAMA.doi:10.1001/jama.2020.16349

McCreary EK, Angus DC.Efficacy of remdesivir in COVID-19.JAMA.doi:10.1001/jama.2020.16337

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