As per the statement issued by FDA, the monoclonal antibodies, casirivimab and imdevimab, should be administered for treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of SARS-CoV-2 testing and who are at high risk of COVID-19.
“Authorising these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said Stephen Hahn, commissioner of the FDA.
The agency added the antibodies are not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalised due to COVID-19.
Regeneron’s antibody treatment is the second synthetic antibody treatment to receive an emergency use approval (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted the status on November 9.
The human immune system naturally develops infection-fighting proteins called antibodies — but because not everyone mounts an adequate response, companies like Regeneron and Lilly have manufactured lab-made solutions.