Regeneron’s antibody cocktail, a part of Trump’s coronavirus treatment, received an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) on Saturday.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn.
Regeneron’s antibody cocktail contains two monoclonal antibodies – casirivimab and imdevimab – which are “specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells”.
The EUA is, however, a different approval, as the FDA warns that it has concluded that the “potential benefits of these antibodies outweigh the known and potential risks”.
“There are no adequate, approved and available alternative treatments to casirivimab and imdevimab administered together for the authorized population”, the FDA warned.
The antibody cocktail was part of Trump’s COVID-19 coronavirus therapy in early October, when he tested positive for COVID-19 and was admitted to Walter Reed Army Medical Center. Trump enjoyed the results of his treatment, boasting of a speedy recovery and praising Regeneron’s drug, noting that he would have been “in much worse shape” had he not been given the antibody cocktail.
After his recovery, Trump said that he was pushing to get Regeneron’s antibody cocktail approved and made available for hospitals to purchase.
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