FDA Approves Remdesivir as First Treatment For COVID-19

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.

Previously, the FDA had granted Emergency Use Authorization (EUA) for remdesivir, not full approval. The first EUA, issued on May 1, said remdesivir could be used in hospitalized patients with severe COVID-19. The EUA was reissued on August 28, expanding use to hospitalized adults and children with confirmed or suspected cases COVID-19, irrespective of their severity of disease.

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 reissued another EUA for remdesiver use in:

• Hospitalized pediatric patients who weigh 3.5 kg to less than 40 kg
• Hospitalized pediatric patients less than 12 years of age who weigh at least 3.5 kg

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, MD in a statement. “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. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

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, explains Matthew D. Hall, PhD, who works at the National Center for Advancing Translational Sciences at the National Institutes of Health. He helped make the COVID-19 OpenData Portal to 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.”

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:

• A patient with oxygen saturation less than or equal to 94%
• A patient requiring supplemental oxygen
• A patient requiring mechanical ventilation
• A patient requiring extracorporeal membrane oxygenation

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.

“I think that we all agree it would be good for people who are just a little unwell at home could take an antiviral to eradicate the virus from their bodies sooner to ensure they don’t get sicker later,” Hall says. “Right now, you’ve got to wait until you’re sick enough to be in hospital to get remdesivir. It’d be great to make sure those people are never sick enough to go to the hospital by giving them an antiviral earlier like Tamiflu for the flu, (where) you go to the doctor, get the pill and it will shorten the time you’re sick for.”

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:

• For adults and pediatric patients weighing 40 kg and higher, the recommended dose is 200 mg on day 1 followed by subsequent doses of 100 mg.
• For pediatric patients weighing between 3.5 kg and 40 kg, the recommended dose is 5 mg/kg on day 1 followed by subsequent doses of 2.5 mg/kg.
• For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation, the recommended total treatment duration is 5 days.
• For patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation, the recommended total treatment duration is 10 days.
• If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.

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.

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 in The 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 the New England Journal of Medicine from 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, the Journal of the American Medical Association published 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.

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 the Journal of the American Medical Association on 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’s Next for Remdesivir?

More clinical trials are underway, according to the Gilead Sciences website. The company is also in the first phase of development to formulate remdesivir as an inhaler.

Hall says the global community has risen to the challenge, but the search for a drug for SARS-CoV-2 has been compounded by the fact that there are no therapeutics for human coronaviruses. The recent SARS and MERS outbreaks were fought through public health measures, not therapeutics.

"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 our coronavirus news page.