Remdesivir on Thursday became the first drug to be fully approved by the United States Food and Drug Administration (FDA) for treating the coronavirus.
The antiviral produced by the pharmaceutical company Gilead Sciences received an emergency use authorization from the FDA in May; Thursday’s announcement will likely expand its usage across the nation. The drug has been approved for the treatment of patients requiring hospitalization.
Remdesivir showed promising results for treating COVID-19 in a much-discussed clinical trial conducted in the spring and early summer. After this trial, White House health advisor and NIAID Director Dr. Anthony Fauci proclaimed to the nation that remdesivir “will be the standard of care” moving forward for coronavirus-positive inpatients. He called the trial results “quite good news.”
The University of Alabama at Birmingham (UAB) was a participating clinical site in the now-famous study and administered the drug to participating patients. However, UAB’s involvement goes significantly farther.
As reported by Yellowhammer News in February, a drug discovery program housed at UAB led to the development of remdesivir. This discovery came from a public-private partnership that also included Birmingham-based Southern Research and Gilead Sciences.
The drug discovery was funded by federal monies awarded to the Antiviral Drug Discovery and Development Center at UAB after U.S. Senator Richard Shelby (R-AL) became chair of the U.S. Senate Committee on Appropriations.
Remdesivir was taken by President Donald J. Trump in his recovery from COVID-19, along with Regeneron’s experimental polyclonal antibody cocktail. That cocktail is currently being tested at UAB.
In a Thursday release, Gilead explained the treatment guidelines for remdesivir and reacted to the FDA approval.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis. 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,” stated Daniel O’Day, chairman and CEO of Gilead Sciences. “The speed and rigor with which [remdesivir] 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 [remdesivir] to ensure all patients with COVID-19 have the best chance at recovery.”
Sean Ross is the editor of Yellowhammer News. You can follow him on Twitter @sean_yhn
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