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FDA Approves Remdesivir for the Treatment of COVID-19

FDA Approves Remdesivir for the Treatment of COVID-19

It’s the first approved therapy for the disease in the United States.

Updated on October 22, 2020 at 6:00pm EDT.

The U.S. Food and Drug Administration (FDA) approved the antiviral drug, remdesivir (Veklury), for the treatment of COVID-19 that results in hospitalization. The drug, made by Gilead Sciences, is now the first and only approved therapy for the disease in the United States.

“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,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences in a news release.

The FDA gave the drug a green light for use among adults and children age 12 and older who are at least 88lbs that have been hospitalized with COVID-19. The antiviral medication works by blocking the coronavirus’ ability to replicate.

This approval is based on three randomized controlled trials, which showed that treatment with the drug resulted in “clinically meaningful improvements” compared to placebo among people hospitalized with COVID-19. Remdesivir was shown in these clinical trials to shorten the time to recovery and reduce the progression of the disease in some patients.

“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,” said Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York in a news release.

In May 2020, the FDA issued an emergency use authorization (EUA) for the antiviral drug as a treatment for severe COVID-19 in adults and children. In August, the agency expanded its EUA to include to include the treatment of all adults and children hospitalized with suspected or confirmed COVID-19, regardless of the severity of their infection.

President Trump is among the COVID-19 patients treated with remdesivir. His medical team revealed he was treated with the drug after testing positive on October 2.

Medically reviewed in October 2020.

Sources:
Gilead. “U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19.” Oct 22, 2020.
Physician to the President, The White House. “President Donald J. Trump and First Lady Melania Trump’s COVID-19 Tests.” October 1, 2020.
U.S. Food and Drug Administration. “COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19.” August 2020.
Ye W, Yao M, Dong Y, et al. Remdesivir (GS-5734) Impedes Enterovirus Replication Through Viral RNA Synthesis Inhibition. Front Microbiol. 2020;11:1105. Published 2020 Jun 12.

 

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