The FDA granted emergency use authorization to Regenron's COVID-19 antibody treatment Nov. 21, the only other COVID-19 antibody treatment granted emergency approval by the agency since its Nov. 9 approval of Eli Lilly's bamlanivimab.
The treatment is a combination of casirivimab and imdevimab, two antibodies that fight against COVID-19. The agency is allowing the antibody cocktail, which is administered intravenously as a one-time treatment, to be used in COVID-19 patients age 12 and over who weigh at least 88 pounds and have a high risk of their case becoming severe.
The FDA did not approve the antibody cocktail's use in COVID-19 patients who are hospitalized or require oxygen therapy.
"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” FDA Commissioner Stephen Hahn, MD, said in a news release. "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."