US grants EUA approval for remdesivir as a COVID-19 treatment

Based on available top-line data from two clinical trials, the US Food and Drug Administration on Friday issued an emergency use authorization for the investigational antiviral drug remdesivir, a compound US biotech major Gilead Sciences (Nasdaq: GILD) had originally developed as a potential Ebola treatment, though never approved as such, that it has repurposed for COVID-109.

The EUA allows for remdesivir to be distributed in the USA and administered by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use, said the FDA.