The Food and the Drug Administration ( FDA ) on Sunday issued an emergency use authorization (EUA) for convalescent plasma gathered from people who have recovered by COVID-19 as a treatment for hospitalized coronavirus patients. More than 70,000 COVID-19 patients in the U.S. have received plasma through a government-funded program during the pandemic; however, the regulator also said that convalescent plasma should not be considered the standard of care at this time. The EUA was issued to the Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. An EUA is not an approval but has become a common way for the regulator to speed up access to still investigational treatments during the pandemic. Gilead Sciences Inc.'s (GILD) experimental drug remdesivir, for example, received an EUA several months ago as a treatment for some hospitalized COVID-19 patients. "The data from studies conducted this year shows that plasma from patients who've recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus," FDA commissioner Dr. Stephen Hahn said in a statement. "At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma."
Jaimy Lee ; 415-439-6400; AskNewswires@dowjones.com
(END) Dow Jones Newswires
08-23-20 1758ET
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