Regeneron’s COVID-19 Antibody Treatment Wins FDA Emergency Use Authorization

Regeneron has won Emergency Use Authorization from the FDA for its investigational antibody cocktail for treatment of patients with mild-to-moderate COVID-19 symptoms at high risk of severe disease progression or hospitalization.

The cocktail, a combination of two monocloncal antibodies, casirivimab and imdevimab —previously called REGN-COV2 — was supported by positive phase 2/3 data that showed the treatment significantly reduced the number of medical visits needed by 800 nonhospitalized COVID-19 patients.

The monoclonal antibodies mimic the body’s immune function to block the COVID-19 spike protein from invading healthy cells. The New York-based drugmaker said the treatment has the most benefit “when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.”

Regeneron CEO Leonard Schleifer said demand may exceed supply initially, making it “even more critical that federal and state governments” ensure the cocktail is “distributed fairly and equitably to the patients most in need.”