FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences, Inc. for the investigational antiviral drug remdesivir – which has been shown to shorten recovery time in some #COVID19 clinical trial patients – to treat suspected or confirmed #COVID19. fda.gov/news-events/pr… 
This EUA allows for remdesivir to be distributed in the U.S. & administered intravenously in adults & children with severe #COVID19 disease, defined as low blood oxygen levels or needing oxygen therapy or more intensive breathing support, like a ventilator.
Issuing an EUA is different than FDA approval. In determining whether to issue an EUA, FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.
After reviewing EUA criteria & the science, we determined it reasonable that remdesivir may be effective in treating #COVID19, & that, given a lack of adequate, approved, or available alternative treatments, the known & potential benefits outweigh the known & potential risks.
Today’s action is an important step in our efforts to collaborate with innovators & researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe & effective.
There’s tremendous interest among all parties to identify medicines to combat #COVID19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts. fda.gov/drugs/coronavi…
