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Remdesivir Approved as First COVID-19 Treatment

In a move heralding the first COVID-19 treatment to receive approval from the U.S. Food and Drug Administration (FDA), the antiviral drug remdesivir has been approved for treating patients hospitalized with COVID-19.

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remdesivir bottles
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In a move heralding the first COVID-19 treatment to receive approval from the U.S. Food and Drug Administration (FDA), the antiviral drug remdesivir has been approved for treating patients hospitalized with COVID-19. The FDA notes that remdesivir, which is indicated for patients ages 12 and older and weighing at least 40 kilograms, should only be administered in a hospital or other healthcare setting capable of providing acute care comparable to inpatient hospital care.

The approval stems from the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild to severe infections. “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” says FDA Commissioner Stephen M. Hahn, MD. “This approval is supported by data the agency has rigorously assessed and represents an important scientific milestone in the global pandemic.”

Self-Test Authorized

On November 17, the U.S. Food and Drug Administration issued an emergency use authorization for the first selfadministered COVID-19 diagnostic test. Available by prescription and offering results in 30 minutes, the test is designed for patients who may have COVID-19, as determined by their healthcare provider. Besides home use, the test is indicated for point-of-care settings, including dental and medical offices, hospitals, urgent care centers, and emergency departments.

 

In a related development that speaks to the conflicting information unfolding as science seeks to understand SARS-CoV-2, a clinical trial by the World Health Organization suggests remdesivir has no substantial effect on COVID-19 mortality or the length of time spent in the hospital. Critics of the WHO Solidarity Trial note the results have yet to be peer reviewed.

From Decisions in Dentistry. December 2020;6(11): 7.

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