FDA Approves Remdesivir for COVID-19 Requiring Hospitalization

In a recent press release the US Food and Drug Administration (FDA) has officially approved remdesivir (marketed as Veklury) as a treatment for cases of COVID-19 that require hospitalization. It can be used on patients age 12 or older and can only be administered in a hospital or hospital-like setting in patients whose diagnosis has been laboratory confirmed. This medication has been used to treat COVID-19 since May 1st, when the agency issued an Emergency Use Authorization (EUA) for the drug.

Initially, this therapy was only used on the most severe cases, but the indication of the EUA was expanded on August 28th to cover all cases that required hospitalization. Veklury was developed by Gilead Sciences, Inc. The drug has shown benefit in trials and in animal and cell culture models of COVID-19. The FDA has determined that the potential benefits of treatment with the drug outweigh potential and known risks. 

Veklury is classified as an inhibitor of RNA polymerase. The drug is issued in 100mg vials and is administered intravenously. In US trials, treatment with this medicine was able to shorten recovery time for some patients. However, these results were not replicated in studies conducted elsewhere.

The approval makes Veklury the first and only drug officially cleared by the FDA for the treatment of COVID-19. As the medical and scientific world have struggled to find effective treatments for the virus and gain a better understanding of its varied impacts, Veklury, along with a few other medicines such as dexamethasone, have stood out as some of the most useful interventions. 

At this juncture, Veklury is widely available across the US and it will likely play an important role in stemming the tide as the COVID-19 pandemic continues to haunt the nation and the world at large. Scientists have feared a new wave of cases this fall and winter, and so far, their dire predictions appear to be coming true with cases on the rise across the US and in many parts of Europe. France, for instance, recently surpassed 1 million recorded cases.

Though most areas of the US have attempted to return to normalcy, the fact remains that the virus responsible for COVID-19 is not under control in any way. Stay home as much as possible and wash your hands frequently. Avoid crowded places, social distance, and if you must venture out, wear a mask.

 

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