Regeneron’s COVID-19 Antibody Cocktail Wins UK Approval
The UK’s Medicines and Healthcare products Regulatory Agency has approved Regeneron’s antibody cocktail Ronapreve (casirivimab/imdevimab) — known as REGEN-COV in the U.S. — for preventing and treating COVID-19.
The conditional marketing authorization was supported by positive results from two phase 3 trials that evaluated the cocktail’s ability to prevent symptomatic infection in high-risk, nonhospitalized patients. The drug has also been shown to retain effectiveness against variants of concern, including the Delta strain.
In the U.S., REGEN-COV received a revised FDA indication approval earlier this month for prevention of COVID-19 infection in individuals 12 years and older who have been exposed to the coronavirus and are at high risk of progressing to severe disease.