WASHINGTON, D.C. — The Food and Drug Administration. has given approval for experimental treatment for people 12- years-old and older that was given to President Donald Trump while he was hospitalized at Walter Reed Medical Center in early October with COVID-19.
Regeneron Pharmaceuticals Inc., on Saturday, was issued emergency authorization from the FDA just as the number of confirmed coronavirus cases in the U.S. reached a record 12 million cases on Saturday, a million more than the 11 million cases announced last Sunday.
Regeneron's antibody therapy consists of two drug products, casirivimab and imdevimab.
The two drugs are injected intravenously, and at the same time.
They are directed against the spike protein of SARS-CoV-2, the virus that causes COVID-19, and designed to block the virus' attachment and entry into human cells.
Cells multiply in the body, both good cells and bad cells.
The newly approved antibody therapy is not a cure but is an experimental shot of lab-generated antibodies that boost the immune system's defenses and mimics how the body would mount a reaction to a foreign invader like COVID-19.
It is the second approval of such antibody therapy by the FDA, which, on Nov 9 gave the go-ahead to the Eli Lilly inc drug bamlanivimab, a similar drug that is also for people 12 and older with mild or moderate COVID-19.
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