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FDA Greenlights Gilead Sciences' Remdesivir as First Fully Approved US COVID-19 Treatment

© AFP 2023 / ULRICH PERREYOne vial of the drug Remdesivir lies during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020, amidst the new coronavirus COVID-19 pandemic
One vial of the drug Remdesivir lies during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany on April 8, 2020, amidst the new coronavirus COVID-19 pandemic - Sputnik International
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The US Food and Drug Administration (FDA) on Thursday approved antiviral drug remdesivir as a COVID-19 treatment, making it the first approved treatment in the US for the novel coronavirus.

The drug, developed by Gilead Sciences, received emergency use authorization from the FDA in May, which allowed hospitals and doctors to administer the drug to hospitalized COVID-19 patients.

“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement to CNBC. “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 US that is available for all appropriate patients in need.”

Gilead also released a statement on Twitter referring to the FDA's approval of the drug as a "milestone" that reflects a "shared commitment" to the fight against COVID-19.

The company in August announced that it is planning on producing more than 2 million treatment courses of the drug by the end of the year, CNBC reported. Its manufacturing network has also been expanded to over 50 companies in North America, Europe and Asia.

Most patients who get treated with remdesivir receive a five-day treatment course. The drug is currently administered intravenously, but the company is working on developing an inhaled version. The drug cannot be taken in a pill due to causing adverse effects on the liver in that form.

When US President Donald Trump tested positive for COVID-19 earlier this month, he was administered remdesivir, which has been shown to reduce the duration of the illness.

"It's not really a treatment in the sense that it'll cure people," Dr. Irwin Redlener, director of the Pandemic Resource and Response Initiative at Columbia University's National Center for Disaster Preparedness, said earlier this month on MSNBC, NBC News reported. "It will just hopefully reduce the fatality rate and reduce the course of the illness."
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