Approved Treatment

[XCR1250]

FDA Approves Remdesivir (Veklury) to Treat COVID-19

Jennifer Tran, PharmD, RPh

Jennifer Tran, PharmD, RPh

November 2, 2020, 12:18PM (PT)

Finding a cure or vaccine for COVID-19 has been a top priority around the world. While there’s still a lot to learn about the disease and how to best manage it, researchers have been making progress over the past few months. For one, the FDA has approved the first treatment for COVID-19: remdesivir (Veklury). Here’s a look at the medication, including how it works, its side effects, and why it was approved.

What is remdesivir?

Remdesivir is an antiviral medication that is given by intravenous (IV) infusion in the hospital. It previously showed some effect against viruses such as SARS, MERS, and Ebola in cell and animal models. 

In a more recent in vitro study (studies done in a petri dish or test tube rather than in animals or humans), remdesivir prevented human cells from being infected with SARS-CoV-2 (the virus that causes COVID-19).

When was remdesivir approved to treat COVID-19?

On October 22, 2020, the FDA approved remdesivir for patients 12 years and older and weighing at least 40 kg (88 lbs) to treat COVID-19 requiring hospitalization. It works by blocking an enzyme that is needed for the SARS-CoV-2 viruses to replicate.

Prior to the FDA approval, remdesivir was available by joining a clinical trial, via a compassionate use program, or under an Emergency Use Authorization (EUA). The intent of the EUA was to make it easier for doctors to get remdesivir for hospitalized patients, particularly those who did not qualify for a clinical trial. Now that remdesivir is approved for certain patients, the EUA only applies to children under 12 or weighing less than 40 kg (88 lbs).

Why was remdesivir approved?

Remdesivir was approved based on findings from three different studies. Safety data from patients who got remdesivir through the EUA or compassionate use program was also considered. In general, patients who got remdesivir recovered faster and were more likely to improve compared to those who did not get the medication.

In the first study, hospitalized patients who got remdesivir recovered faster than those who got a placebo (10 days vs. 15 days, respectively). Patients were considered to have “recovered” if they were discharged from the hospital or were still hospitalized but no longer needed extra oxygen support. Additionally, patients with mild or moderate disease who got remdesivir recovered faster (5 days) than those with severe disease (11 days).

The second study looked at hospitalized patients with severe COVID-19. A patient’s clinical status was rated on a 7-point scale based on how well they were doing and the level of care needed in the hospital. On day 14, patients who got remdesivir for 5 days had a similar clinical status score as those who got remdesivir for 10 days. This suggests that 5 days of remdesivir is a sufficient length of time for most patients.

The third study looked at hospitalized patients with moderate COVID-19. These patients’ health statuses were also rated on a 7-point scale. On day 11, patients who got 5 days of treatment with remdesivir were more likely to improve compared to those who did not get the medication. Interestingly, those who got remdesivir for 10 days did not see much difference compared to patients who did not get it.

What are the side effects of remdesivir?

The most common side effect of remdesivir is nausea. Changes in liver blood tests and kidney function tests were also reported, which are signs of potential liver or kidney damage, respectively. That said, having COVID-19 can also cause changes in liver function, so it’s difficult to know how much remdesivir contributed to the liver test findings.

Since remdesivir is given via an IV infusion, some people can also have a reaction related to the infusion itself. This might result in changes in blood pressure and heart rate, nausea, and vomiting. Slowing down the infusion can help prevent this.

How can I get remdesivir?

Remdesivir is only available for hospitalized patients with COVID-19. It is given by IV infusion for 30 to 120 minutes. It is not available for patients to take at home.

 

[XCR1250]

https://www.nytimes.com/2020/11/05/health/coronavirus-ferrets-vaccine-spray.html