COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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Second Monoclonal Antibody Treatment for COVID-19 Authorized for Treatment of Mild to Moderate Infections

FDA maze of regulations

EUA for new monoclonal antibody treatment requires positive COVID-19 test results before using as an investigational therapy for use in treatment of mild to moderate cases of COVID-19

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a second monoclonal antibody treatment. This EUA applies to casirivimab and imdevimab administered together by intravenous (IV) infusion and used to treat patients who are 12 years old or older and weighing over 40 kilograms (about 88 pounds), and who have a positive direct SARS-CoV-2 viral test result.

“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 Stephen M. Hahn, MD, said while announcing the new EUA. “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.”

This EUA was issued to Regeneron Pharmaceuticals, Inc., Nov. 21, 2020, and can only be used to treat mild to moderate cases of COVID-19. A positive direct SARS-CoV-2 viral test result is required to provide a patient with this monoclonal antibody treatment.

The first EUA was issued Nov. 10, 2020, for Eli Lilly and Company for its investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

For more information, including provider fact sheets, visit Eli Lilly: Bamlanivimab for COVID-19 and Regeneron: Authorized for FDA Emergency Use only Casirivimab and Imdevimab.

Related Resources:

FDA: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

FDA Regeneron EUA Letter

FDA Eli Lilly and Company EUA Letter

Recent Regulatory Updates from COVID-19 STAT