The US Food and Drug Administration on Saturday issued the Emergency Use Authority for Rengan Pharmaceuticals Inc.’s COVID-19 antibody therapy, an experimental treatment given to US President Donald Trump, in which he said he would be able to treat the disease. Has helped.
The FDA stated that monoclonal antibodies, cacirivimab and imdevimab should be administered simultaneously in adults and pediatric patients for the treatment of mild to moderate COVID-19, with positive results from direct SARS-COV-2 viral testing and which Are at high risk for progress. For severe COVID-19.
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This includes people who are 65 years of age or older or who have some chronic medical conditions.
The treatment is part of a class of drugs known as monoclonal antibodies, which are copies of antibodies made by the human body to fight infection.
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Regeneron’s REGEN-COV2 “antibody cocktail” – an antibody created by the company and a second isolated from humans recovered from COVID-19 – so that both antibodies seek out and bind the spike protein of the corvirus to prevent it. Entry into healthy human cells.
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Regeneron said Saturday that clinical evidence from outpatient testing showed that diagnostic antibodies such as REGEN-COV2 have the greatest benefit when diagnosed and in patients who have not yet received their immune response or who have Has a high viral load.
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The company said it expects REGEN-COV2 to treat about 80,000 patients by the end of this month, about 200,000 patients by the first week of January, and about 300,000 patients in total by the end of January.
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The FDA stated that antibodies are not authorized for patients who have been hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
(Reporting by Ram Venkat and Manas Mishra in Bengaluru; Editing by Dan Grebler)