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Regeneron Covid Drug Gets Emergency OK

Antibody drug cocktail casirivimab and imdevimab are allowed for use by people over age 12 with mild or moderate Covid-19.
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The Food and Drug Administration granted over the weekend an emergency use authorization for Covid-19 treatments by Regeneron  (REGN) - Get Regeneron Pharmaceuticals, Inc. Report -- casirivimab and imdevimab -- which the authority says can now be given together to treat mild to moderate disease in people older than age 12.

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, in a press statement.

A clinical trial of patients infected with the coronavirus showed that casirivimab and imdevimab, when given together and administered via intravenous infusion, cut down Covid-19-related hospitalization in high-risk patients within 28 days after treatment when compared to placebo, said the FDA. 

But, the agency noted, the safety and effectiveness of the therapy "continues to be evaluated," and they are not authorized for patients who are already hospitalized with Covid-19, or require oxygen therapy. 

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The FDA further said that monoclonal antibodies might be associated with worse outcomes in Covid patients needing high flow oxygen or mechanical ventilation.

Monoclonal antibodies are synthetic proteins that "mimic" the immune system’s ability to fight off viruses and other pathogens, said the FDA. 

Several other companies have been working on products using the technology or that are related to the technology, including Japanese drugmaker Takeda  (TAK) - Get Takeda Pharmaceutical Co. Ltd. Report, Emergent BioSolutions  (EBS) - Get Emergent BioSolutions Inc. Report and Eli Lilly  (LLY) - Get Eli Lilly and Company Report.

The Regeneron product made big headlines recently when it was given to President Donald Trump after he was tested positive for Covid-19.