FDA issues emergency use authorization to Regeneron for COVID antibody treatment

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization to Regeneron Pharmaceuticals for its monoclonal antibodies -- casirivimab and imdevimab -- to be given together to treat mild to moderate COVID-19 in adults and in kids over age 12.

The treatment should be given to patients who have a positive coronavirus test and face a high risk of getting severe COVID-19, including those who are 65 and older or have certain chronic medical conditions.

“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” Stephen Hahn, MD, commissioner of the FDA, said in a statement.

Casirivimab and imdevimab must be given together through an IV. The lab-made proteins mimic the immune system and specifically target the spike protein on SARS-CoV-2, blocking the virus from entering human cells.

In a clinical trial of nearly 800 patients, the antibody treatment was shown to reduce COVID-19 hospitalizations and emergency room visits in patients who had a high risk of their disease getting worse. Within 28 days of treatment, 3% of people who took the treatment were hospitalized, compared with 9% of people who received the placebo.

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