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November 22, 2020

FDA grants emergency use authorization to Regeneron COVID-19 antibody cocktail

The therapeutic was taken by President Donald Trump when he was diagnosed with the coronavirus in October

The U.S. Food and Drug Administration has issued an emergency use authorization for Regeneron’s COVID-19 antibody cocktail that was taken by President Donald Trump in October after being diagnosed with the coronavirus.

The FDA’s authorization allows for casirivimab and imdevimab to be administered together via an IV in order to treat mild or moderate COVID-19 cases in adults and children, the government agency announced.

Recipients of the monoclonal antibodies must be 12 years of age or older, weigh at least 88 lbs., and be at high risk of progressing to a severe case of COVID-19. Individuals ages 65 and older or who have underlying health conditions qualify as well.

When a clinical trial of almost 800 non-hospitalized patients diagnosed with mild or moderate coronavirus symptoms were treated with casirivimab and imdevimab together, the antibody cocktail was shown to reduce COVID-19-related hospitalizations and emergency room visits in patients who are at high risk for developing a severe case of the virus within 28 days after treatment. 

The monoclonal antibodies were administered within three days of the participants receiving a positive COVID-19 test.

Casirivimab and imdevimab, however, are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to the virus. A positive response to receiving the antibody cocktail has not been shown yet in patients hospitalized due to the coronavirus. 

Monoclonal antibodies, in fact, may be associated with worse clinical outcomes when given to hospitalized patients with COVID-19 requiring high flow oxygen or ventilation.

“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,” FDA Commissioner Dr. Stephen Hahn said. 

“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.” 

Monoclonal antibodies are laboratory-made proteins that duplicate the immune system’s ability to fight off viruses. Casirivimab and imdevimab are specifically directed against the spike protein of COVID-19 to block the virus’ attachment and entry into human cells.

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Dr. Patrizia Cavazzoni, who serves as 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.”

The safety and effectiveness of the antibody cocktail for use in the treatment of COVID-19 continues to be evaluated.

Healthcare providers, patients, and caregivers must be provided with information about using casirivimab and imdevimab administered together in treating COVID-19 as authorized. That information must include dosing instructions, potential side effects, and drug interactions. Possible side effects of casirivimab and imdevimab include anaphylaxis and infusion-related reactions, fever, chills, hives, itching and flushing.

U.S. officials have suggested a coronavirus vaccine could become available in limited capacity late this year or early 2021, with widespread distribution to the general public not expected until sometime next spring.

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