PP_1170x120_10-25-21

FDA grants emergency use authorization to Regeneron’s COVID-19 antibody

Print Friendly, PDF & Email

WASHINGTON — The U.S. Food and Drug Administration on Saturday issued emergency use authorization for Regeneron’s COVID-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease.

The 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.

Regeneron’s REGEN-COV2 “antibody cocktail” – containing an antibody made by the company and a second isolated from humans who recovered from COVID-19 – is designed so that the two antibodies seek out and bind to the coronavirus’ spike protein to prevent it from entering healthy human cells.

Regeneron said  the clinical evidence from outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.


ECRM-08-202222

Adheris Health

Comments are closed.

Adheris Health