FDA Issues Emergency Use Authorisation for Convalescent Plasma as Potential Promising COVID–19 Treatment
Based on scientific evidence, including use in more than 70,000 US pts, the FDA concluded convalescent plasma may be effective in treating suspected/laboratory-confirmed COVID-19 in hospitalised pts and that known and potential benefits outweigh known and potential risks.
Source:
US Food and Drug Administration
SPS commentary:
The FDA continues to recommend that the designs of ongoing RCTs of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.