09-08-2022, 11:55 AM
The move comes about half a year after the FDA pulled the cocktail from the market after data suggested its efficacy had waned in the face of the surging omicron variant.
It’s a fate shared by a number of early-pandemic therapeutics, which have largely fallen by the wayside in the U.S. as the virus swiftly evolves.
Now, Regeneron has terminated four clinical trials of REGEN-COV, comprising the monoclonal antibodies casirivimab and imdevimab.
On the FDA’s online roster of pandemic emergency use authorizations, the regulator states that both Regeneron’s REGEN-COV and Lilly’s bamlanivimab and etesevimab are “not currently authorized in any U.S. region,” and therefore, “may not be administered for the treatment or post-exposure prevention of COVID-19.”
https://www.fiercepharma.com/pharma/rege...-treatment
It’s a fate shared by a number of early-pandemic therapeutics, which have largely fallen by the wayside in the U.S. as the virus swiftly evolves.
Now, Regeneron has terminated four clinical trials of REGEN-COV, comprising the monoclonal antibodies casirivimab and imdevimab.
On the FDA’s online roster of pandemic emergency use authorizations, the regulator states that both Regeneron’s REGEN-COV and Lilly’s bamlanivimab and etesevimab are “not currently authorized in any U.S. region,” and therefore, “may not be administered for the treatment or post-exposure prevention of COVID-19.”
https://www.fiercepharma.com/pharma/rege...-treatment