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FDA Approves Remdesivir to Treat COVID-19

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October 23, 2020 -- The pharmaceutical company Gilead Sciences announced that the FDA has approved the antiviral drug remdesivir for treating COVID-19, the company said Thursday in a news release.

Remdesivir becomes the first drug to receive full approval from the FDA for treatment against the coronavirus, Gilead said.

In May, the FDA gave emergency use authorization for remdesivir, which allowed doctors to use it on patients during this public health crisis even though it had not been fully approved by the agency.

Remdesivir is sold under the brand name Veklury and is believed to shorten recovery time for people hospitalized with the coronavirus. President Trump was one of the coronavirus patients treated with remdesivir.

The Gilead news release said approval was based on three randomized controlled trials.

Remdesivir will be given to coronavirus patients who are at least 12 years old and require hospitalization, Gilead said.

“The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York, said in the Gilead news release.

“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” said Daniel O’Day, chairman and CEO of Gilead. “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.”

The World Health Organization recently announced that a large study found that remdesivir doesn’t help hospitalized patients with COVID-19 survive and doesn’t even shorten the recovery time of those who do survive.

The WHO-sponsored study was conducted from March 22 to Oct. 4 and involved 11,330 patients from 405 hospitals in 30 countries. The data was posted online in the preprint server medRxiv and has not been peer-reviewed or published in a scientific journal.

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Sources

Gilead Sciences. “U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19.”

FDA. “Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment.”
 

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