The Food and Drug Administration on Saturday granted an emergency use authorization for the experimental antibody treatment given to Donald Trump when he was hospitalized with COVID last month.
The drug from Regeneron is a cocktail of two monoclonal antibodies that mimics the human body’s natural defenses to a virus.
The drug has been authorized to treat mild to moderate COVID cases in adults and children older than 12 years old who are at a high risk for progressing to severe COVID-19. The drug is not authorized for patients who are hospitalized with COVID or require oxygen therapy due to COVID-19.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic,” FDA Commissioner Stephen Hahn said. “Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system.”
The company filed for emergency approval of the treatment in October after Trump praised its efficacy in a video posted on Twitter. The treatment was one of several that he received during his stay at Walter Reed National Military Medical Center to treat his COVID-19 diagnosis last month, The Hill reports.
The company says it will have enough antibody doses for about 80,000 people by the end of this month and about 300,000 by the end of January.
That still won’t be enough. That’s why the company will be working with Roche to boost its production so by next year they can produce up to 8 million dosed to prevent Americans from getting sick with the virus.