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US FDA grants emergency use permit for Trump’s Regeneron COVID-19 antibody



The US Food and Drug Administration on Saturday issued an emergency authorization for Regeneron Pharmaceuticals Inc’s anti-COVID-19 antibody therapy, an experimental treatment given to US President Donald Trump that he said helped him cure the disease.

The FDA has stated that monoclonal antibodies, kazirivimab and imdevimab, should be used together to treat mild to moderate COVID-19 in adult and pediatric patients who test positive for SARS-CoV-2 and who are at high risk. to progress to severe COVID-1

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This includes those who are 65 or older or who have certain chronic diseases.

Treatment is part of a class of drugs known as monoclonal antibodies, which are produced copies of antibodies created by the human body to fight infections.

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Regeneron’s REGEN-COV2 “antibody cocktail” – containing an antibody made by the company and secondly isolated from humans recovered from COVID-19 – is designed so that both antibodies search for and bind to the coronavirus crown protein. to prevent it from entering healthy human cells.

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Regeneron said on Saturday that clinical data from an outpatient study showed that monoclonal antibodies such as REGEN-COV2 were most useful when given early after diagnosis and in patients who had not yet established their own immune response or had a high viral load. .

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The company said it expects to be ready for treatment with REGEN-COV2 for about 80,000 patients by the end of this month, about 200,000 patients by the first week of January and a total of about 300,000 patients by the end of January.

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The FDA said the antibodies were not approved for patients who were hospitalized for COVID-19 or needed oxygen therapy for COVID-19.

(Report by Rama Venkat and Manas Mishra in Bengaluru; Editing by Dan Grebler)


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