US grants emergency use authorisation to Regeneron Covid-19 antibodies

The United States has issued an emergency approval for a synthetic antibody therapy against Covid-19 that was notably used to treat President Donald Trump.

The authorisation was given on Saturday to Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy that Trump said helped cure him of the disease.

The Food and Drug Administration (FDA) said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

This includes those who are 65 years of age or older or who have certain chronic medical conditions.

"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.

They work by binding to a surface protein of the SARS-CoV-2 virus and stopping it from invading human cells. 

The FDA said the data supporting Regeneron's EUA came from a clinical trial in 799 non-hospitalised patients with mild to moderate symptoms of Covid-19.

For patients who were at high risk because of a variety of underlying conditions -- from obesity to old age to diabetes -- hospitalization and emergency room visits occurred in three percent of patients who received the intravenous treatment.

This compared to nine percent in placebo-treated patients.

(with inputs)