FDA authorizes injectable version of Regeneron's COVID-19 antibody drug

The FDA has authorized a new version of Regeneron's COVID-19 drug that can be given by injection, which should make it easier to give to patients. 

Regeneron said June 4 the FDA is now allowing the drug, called REGEN-COV, to be given by injection rather than through intravenous infusion. Public health officials have said the drug has been underused in part because not all clinics and hospitals have the ability to administer it intravenously, The Wall Street Journal reported. 

"Unfortunately, to date only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization," George Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in a news release.

The drug, a combination of two monoclonal antibodies, was granted emergency use authorization for treatment against COVID-19 in November. In clinical trials, it reduced the risk of hospitalization or death from COVID-19 by 70 percent in those with mild to moderate symptoms. 

The FDA also allowed for the drug to be combined in a single vial, which could reduce the time it takes to prepare the treatment, the Journal reported. It also cleared a lower dose of the drug that's about half the strength of the original dose, which will increase the total number of doses available for patients. 

Regeneron said it plans to deliver at least 1 million doses to the U.S. by June 30. 

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>