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FDA Issues EUA for Monoclonal Antibodies to Treat COVID-19 in High Risk Patients
The FDA issued an EUA for the investigational antibody cocktail casirivimab and imdevimab for the treatment of mild-to-moderate COVID-19 in high risk patients.
The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the monoclonal antibodies casirivimab and imdevimab to be administered together via intravenous infusion for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in high risk patients.
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The EUA was issued to Regeneron Therapeutics Inc. and authorizes the investigational therapy to be administered together in adults and pediatric patients (aged ≥12 weighing at least 88 lbs.) with confirmed SARS-CoV-2 and who are at high risk for progressing to severe COVID-19 (including adults aged ≥65 years or who have certain chronic conditions).
Casirivimab and imdevimab are specifically directed against the spike protein of SARS-CoV-2 in order 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 Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”
The EUA was issued based on results of a clinical trial of 799 adults with COVID-19, which showed hospitalizations and emergency department visits occurred in 3% of patients who received casirivimab and imdevimab on average vs 9% in placebo-treated patients within 28 days of treatment. The safety and effectiveness of casirivimab and imdevimab for use in the treatment of COVID-19 continues to be evaluated, noted the FDA in the press release.
“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, MD, in the same press release.
Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Possible side effects of casirivimab and imdevimab include anaphylaxis and infusion-related reactions, fever, chills, hives, itching, and flushing.
