FDA Approves Remdesivir as the First COVID-19 Treatment

FDA recently approved Verklury as the first COVID-19 treatment. The approval signs off on using the drug also known as remdesivir has been signed in adults and pediatric patients 12 years of age or older who are infected with the novel coronavirus. 

Previously authorized for emergency use to treat COVID-19 back in May, remdesivir is now the only approved COVID-19 treatment in the US.

The drug is now widely available in hospitals and other healthcare settings across the country and it is capable of providing acute care comparable to inpatient hospital care, according to the announcement. 

“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,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement. 

“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.”

Developed by Gilead, remdesivir was previously used to treat Ebola back in 2013.

In considering the drug, FDA stated that it conducted a benefit-risk assessment based on scientific standards to ensure that the product’s benefits outweigh the risks for the intended population.

The agency’s approval of remdesivir was supported by an analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild to severe COVID-19, FDA said.

The first randomized, controlled clinical trial in the US, sponsored by the National Institutes of Health (NIH), took place at the end of February and evaluated the safety and efficacy of remdesivir in adults infected in COVID-19.

At the time of the trial, participants must have had a confirmed case of the coronavirus and evidence of lung involvement, including rattling sounds when breathing with a need for additional oxygen or abnormal chest x-rays, or illness requiring mechanical ventilation. 

Individuals who had mild, cold-like symptoms, or no symptoms at all, were not eligible to participate in the trial. 

Then in March, a second randomized, open-label multi-label clinical trial of hospitalized patients with moderate COVID-19 compared treatment with remdesivir for five days and ten days. 

Researchers found that overall, the odds of a subject’s COVID-19 symptoms improving were significantly higher in the five-day remdesivir group at Day 11 compared to standard care.

And the third randomized clinical trial of adults with severe COVID-19 compared treatment with remdesivir for five days and ten days and found that COVID-19 symptom improvement was similar for those in the five-day group as those in the 10-day group.

FDA noted that important information about using remdesivir as COVID-19 treatment is available in the prescribing information, which includes dosing instructions, potential side effects, and drug interactions.

“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” Daniel O’Day, chairman and chief executive officer, of Gilead Sciences, said in a press release. 

“The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.”