U.S. FDA issues EUA for convalescent plasma as potential promising COVID-19 treatment
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Sunday for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients.
It is part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product, said a release of the agency.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the United States and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19, said the FDA.
“We’re encouraged by the early promising data that we’ve seen about convalescent plasma. 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,” said FDA Commissioner Stephen Hahn.
Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus.
Prior experience with respiratory viruses and limited data from other countries suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19.
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