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The FDA is canceling the emergency use of monoclonal antibodies to treat symptoms of Corona


The US Food and Drug Administration has revoked the Emergency Use Authorization (EUA) that allowed the use of monoclonal antibody therapy Bamlanivimab, when taken alone, to treat mild to moderate coronavirus symptoms in adults and some children.


According to its official website, and based on its continuous analysis of emerging scientific data, specifically the continuous increase in viral variants, the Food and Drug Administration has determined that the known and potential benefits of bamlanivimab, when taken alone, no longer outweigh the known and potential risks of its authorized use. Therefore, the agency decided that The criteria for issuing an authorization are no longer met and the EUA has been abrogated.


On November 9, 2020, based on all the scientific evidence available at the time, the Food and Drug Administration (FDA) issued an Emergency Use License Agreement to Eli Lilly, allowing the emergency use of bamlanivimab alone to treat mild to moderate coronavirus symptoms in adults and patients. Children (ages 12 years or older and weighing at least 40 kg), who are more likely to develop severe coronavirus.


What are monoclonal antibodies?

 

Monoclonal antibodies are proteins made in the laboratory that mimic the immune system's ability to fight harmful pathogens such as viruses, such as the Coronavirus.


As of mid-March 2021, nearly 20% of viruses sequenced in the United States were reported as variants expected to be resistant to bamlanivimab alone, up from about 5% in mid-January 2021.


In addition, there are currently no testing techniques available that enable health care providers to test individual patients for viral variants of MERS-CoV before starting monoclonal antibody therapy. Therefore, an experimental treatment with monoclonal antibody therapies that is expected to work at scale should be used. A broad spectrum against all variants across the country to reduce the likelihood of treatment failure.

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