FDA Approves Regeneron - Roche's COVID-19 Antibody Cocktail For Post-Exposure Prophylaxis - Roche Holding (OTC:RHHBF), Roche Holding (OTC:RHHVF), Regeneron Pharmaceuticals (NASDAQ:REGN), Roche Holding (OTC:RHHBY)

Following the June update that allowed for a lower dose of REGEN-COV, the FDA has again expanded emergency use authorization for the investigational COVID-19 antibody cocktail.
REGEN-COV (casirivimab and imdevimab) has been developed by Regeneron Pharmaceuticals Inc REGN and Roche Holdings AG RHHBY.
The update enables the already infected individuals and those at high risk of being exposed due to residing in an institutional setting (e.g., nursing homes or prisons) to receive the cocktail.
The release further noted that the cocktail can now also be administered monthly for individuals 12 years of age and older who require repeat dosing for ongoing exposure.
REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus.
REGEN-COV should only be used as post-exposure prophylaxis for specific patient populations. Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19, the FDA noted.
Price Action: REGN shares closed at $574.61, and RHHBY closed at $48.26 on Friday.
Related content: Benzinga's Full FDA Calendar.