As COVID-19 cases increase across the country, the announcement that a drug to treat the virus has been approved by the FDA should be welcome news. But what are the real facts surrounding Remdesivir?
The announcement is clouded by controversy about whether the scientific research supports the decision. Furthermore, conflicting data from a large study appears to lack scientific support for the decision. Some researchers and physicians have expressed concern that the FDA’s approval has more to do with political pressure than actual scientific evidence.
Here are the facts about Remdesivir as we know them.
History of Remdesivir
Remdesivir is a broad-spectrum antiviral drug that is administered intravenously. Gilead Sciences developed it as part of research on treatments for hepatitis C and respiratory syncytial virus (RSV). In 2014 it was studied as a potential treatment for Ebola but failed to prove effective.
In May 2020, it received emergency use authorization from the FDA as a treatment for patients with severe cases of COVID-19. In August, the FDA relaxed its guidelines so that Remdesivir could be used in less severe cases of the virus. On October 22, the FDA granted Remdesivir full approval to treat COVID patients.
The FDA’s decision was the result of three randomized controlled trials that showed some patients who received Remdesivir had shorter hospital stays compared to those who did not receive the drug.
Effect of Remdesivir on Mortality
The World Health Organization (WHO) said preliminary results from a study of almost 12,000 patients worldwide revealed Remdesivir does not decrease the number of people who die from COVID-19. Furthermore, the WHO study data showed the drug had little impact on hospital stay. The information provided from the WHO data gave some researchers and physicians pause about whether the FDA approval was warranted.
Receiving full FDA approval means that Remdesivir is considered the standard of care for patients who end up hospitalized for the virus. Any other potential treatments must be compared to Remdesivir during clinical trials. This can increase the cost of trials for other drugs and make the trials more complex, which in turn can delay the results.
Recruitment of study participants may also be more challenging. Human nature makes people reluctant to try something experimental if they think there is already an effective treatment. The result is that it could take longer to find a more effective drug.
When Use of Remdesivir Is Indicated
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Remdesivir works by interfering with how the virus replicates itself, which results in the virus not being able to reproduce as much in a person. It is approved only for adults and children 12 years or older who weigh at least 88 pounds and only for patients who have been hospitalized.
The drug has a hefty price tag at $3120 for a five-day course of treatment.
Side Effects
All medications have potential side effects, and Remdesivir is no exception. Possible side effects identified by the FDA include:
Increased levels of liver enzymes which is a possible sign of liver damage
- Allergic reactions
- Changes in blood pressure
- Changes in heart rate
- Low blood oxygen levels
- Fever
- Shortness of breath
- Wheezing
- Swelling
- Rash
- Nausea
- Sweating
- Shivering
Only time will tell whether the FDA’s decision was the right one.
Remdesivir Facts — Sources
ACS Central Science – Remdesivir: A Review of Its Discovery and Development Leading to Emergency Use Authorization for Treatment of COVID-19
FDA – FDA Approves First Treatment for COVID-19
Vox – The FDA approved remdesivir to treat Covid-19. Scientists are questioning the evidence