The U.S. Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron Pharmaceuticals Inc.’s Covid-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped treat the disease.
The FDA said monoclonal antibodies, casirivimab and imdevib, should be administered together for the treatment of mild to moderate COVID-19 in adult and pediatric patients who have positive results from the CARARS-CoV-2 viral test and who have high risk for progress. . From severe COVID-19.
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This includes people who are 65 years of age or older or have a long medical condition.
This treatment is part of a class of drugs called monoclonal antibodies, which are replicas of antibodies made by the human body to fight infection.
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Regeneron’s REGEN-COV2 “Antibody Cocktail”, a human-made antibody made by the company and second only to COVID-19, is designed to detect and combine coronavirus spike proteins to inhibit the two antibodies. Entering healthy human cells
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Regeneron said Saturday that clinical evidence from outpatient trials suggests that monoclonal antibodies have the greatest benefit when given as soon as possible after diagnosis and in patients who have not developed their own immune response or have a high viral load.
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The company said it expects to treat about 1,000,000 patients by the end of this month, about 200,000 by the first week of January, and about 300,000 by the end of January.
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The FDA said antibodies are not authorized for patients who are hospitalized with COVD-19 or in need of oxygen therapy for COVD-19.
(Reporting by Ram Venkat and Manas Mishra in Bengaluru; Editing by Dan Grabler)