The United States Food and Drug Administration (FDA) granted this Saturday an emergency use authorization to the cocktail of two antibodies to treat mild to moderate cases of COVID-19 in patients older than 12 years.
It is the experimental treatment of the drug Regeneron given to President Donald Trump after he tested positive for COVID-19 in October.
In a statement, the FDA explained that a clinical trial showed that the use of casirivimab and imdevimab, administered together, reduces hospitalization time or visits to the emergency room in patients at high risk of progression of COVID-19 within the 28 days after treatment.
Casirivimab and imdevimab must be given together by intravenous (IV) line. They are not authorized for patients who are hospitalized due to COVID-19 or who require oxygen therapy for the same virus.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight harmful pathogens such as viruses. Casirivimab and imdevimab specifically target the SARS-CoV-2 protein spike, designed to block the virus from binding and entering human cells.
“The FDA remains committed to advancing the public health of the country during this unprecedented pandemic. Licensing these monoclonal antibody therapies can help outpatients avoid hospitalization and ease the burden on our health care system, “said FDA Commissioner Stephen M. Hahn, MD.
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After overcoming COVID-19, Trump affirmed that this treatment was the main responsible for his improvement and defined it not as “therapy”, but as a “cure”, despite the fact that there is no scientific evidence to support that conclusion.
When he requested the emergency authorization in October, Regeneron said that, once granted, the US government had “committed to having doses available to Americans at no cost and will be responsible for their distribution.”
The biopharmaceutical then indicated that it had doses for 50,000 patients, but expected to have enough available to treat 300,000 “in a few months.”
The emergency authorization comes on the same day that the United States has exceeded 12 million infections of the new coronavirus and already adds more than 255,000 deaths, more than any other country in the world.