The U.S. Food and Drug Administration (FDA) has given emergency use approval for a monoclonal antibody developed by Regeneron Pharmaceuticals Inc’, an experimental treatment given to U.S. President Donald Trump.
The FDA has approved the usage of monoclonal antibodies Casirivimab and Imdevimab for treating mild to moderate COVID-19 in adults as well as pediatric patients and who are at high risk of progressing into critical condition including those above 65 years and those with a chronic medical history.
Regeneron Pharmaceuticals’ COVID-19 therapy uses a type of drugs known as monoclonal antibodies, which are replicated copies of antibodies developed in the human body to fight infections.
Regeneron’s REGEN-COV2 antibody cocktail contains two types of antibodies, one is made by the company and the other is separated from humans who recovered from COVID-19. These two antibodies seek out and bind to the coronavirus’ spike protein and stop it from intruding into healthy human cells.
The drug is directed to be given as a one-time treatment through an intravenous (IV) infusion. The FDA has authorized its usage in adults and children aged above 12, who weigh at least 88 pounds and those at high risk of severe illness from COVID-19 because of age or certain medical conditions.
The authority has forbidden the administering of Casirivimab and Imdevimab on patients who are hospitalized due to COVID-19 or require oxygen therapy due to the infection as the drug has not created any visible improvement in such patients.
In a statement given, Regeneron stated that the clinical results from the trials show that monoclonal antibodies like REGEN-COV2 have high benefits when used early after diagnosis and in patients who have not yet mounted their own immune response or who have a high viral load.
By the end of this month, the company is expecting to produce REGEN-COV2 for treatment of about 80,000 patients, for 200,000 patients by the first week of January and approximately 300,000 patients in total by the end of January.
The emergency authorization is given by the FDA only acts as a temporary consent for the duration of the COVID-19 pandemic. To get complete approval, Regeneron will have to submit additional research to fully prove the drug’s safety and benefits.
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