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FDA clears emergency use of investigational drug Covid given to Donald Trump

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The US Food and Drug Administration on Saturday issued an emergency use authorization for the Covid-19 antibody treatment from Regeneron Pharmaceuticals Inc., an experimental treatment administered to President Donald Trump that he said helped him recover from disease.

The FDA has said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate Covid-19 in adults and pediatric patients with positive results from direct viral screening for SARS-CoV- 2 and who are at high risk of progression. to severe Covid-19.

This includes people who are 65 years of age or older or who have certain chronic conditions.

The treatment is part of a class of drugs called monoclonal antibodies, which are made copies of antibodies created by the human body to fight infections.

Regeneron’s REGEN-COV2 “antibody cocktail” – containing an antibody made by the company and a second isolated from humans who have recovered from Covid-19 – is designed so that both antibodies seek out and bind to the protein of tip of the coronavirus to prevent it from entering healthy human cells.

Regeneron said on Saturday that clinical evidence from an outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet developed their own immune response or have a high viral load.

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

The FDA has said antibodies are not allowed for patients hospitalized due to Covid-19 or requiring oxygen therapy due to Covid-19.

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