Friday, May 1, 2020

EUAphoria

In an exceptional May Day decision, the United States Food and Drug Administration ("FDA") issued an Emergency Use Authorization ("EUA") "for emergency use of remdesivir for the treatment of
hospitalized 2019 coronavirus disease (COVID-19) patients".  The EUA describes remdesivir as
a direct acting antiviral drug that inhibits viral RNA synthesis.  It is an investigational drug and is not currently approved for any indication.  Remdesivir has activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2. 
It then outlines the scientific evidence undergirding its decision:
Based on review of the topline data from the randomized, double-blinded, placebo-controlled trial conducted by NIAID (NCT04280705) and from the Gilead-sponsored open-label trial that evaluated different durations of remdesivir (NCT04292899), it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19.
Finally, the EUA explains the statutory basis for authorizing use of remdesivir: 
Having concluded that the criteria for issuance of this authorization under 564(c) of the Act are met, I am authorizing the emergency use of remdesivir for treatment of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization.  
There is no guarantee that further data regarding the performance of remdesivir will be similarly positive.  However, the EUA does indicate that the FDA has high hopes for this drug in combating SARS-CoV-2 and the Covid-19 disease it causes.

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