The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a second antibody drug used by President Trump during his battle with COVID-19.
The drug, created by Regeneron Pharmaceuticals, aims to help the immune system stimulate a response to fight the virus. It is given as a one-time treatment through an IV and will be permitted for emergency use among high-risk patients who are 12 and over and at risk for a severe infection.
As an antibody treatment, the drug is a cocktail of two treatments: casirivimab and imdevimab that must be administered together. They are both monoclonal antibodies and work to mimic the immune system’s proteins to help fight off the virus and block entry into human cells.
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A double-blind, placebo-controlled study revealed the beneficial outcomes of COVID-19 illnesses when the cocktail was administered, mainly measured in percentage of emergency room visits among volunteer patients.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Patrizia Cavazzoni, the acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”
Reported by The Associated Press, Regeneron confirmed that the initial doses will be given to about 300,000 patients through government allocation. It will be free for patients.
Notably, casirivimab and imdevimab won’t be authorized for ventilated patients or patients requiring oxygen therapy.
An EUA designation is distinct from FDA approval, and while casirivimab and imdevimab have been authorized for patients at risk of severe illness, officials note that they will continue to monitor the outcomes when using the drug.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
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