Infectious Disease
FDA approves Regeneron antibody cocktail for post-exposure prophylaxis of COVID-19
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Following the June update that allowed a lower dose of Regeneron’s antibody cocktail for the treatment of COVID-19, the FDA has again expanded the emergency approval, this time for use as post-exposure prophylaxis.
According to a press release from Regeneron, the update will allow people who have already been exposed to SARS-CoV-2, as well as people who, due to their stay in an institutional setting (e.g. to receive the cocktail.
“Today’s FDA approval allows certain individuals at high risk of developing severe COVID-19 infection to have access to REGEN-COV if they’ve been exposed to the virus – the first time antibody treatment has been approved for this purpose. ” Georg D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron said in the news release. “With this approval, the FDA is specifically highlighting the needs of immunocompromised people, including those taking immunosuppressive drugs that may not respond adequately to vaccination, those exposed to a person with COVID-19, or who are and are in an institutional setting in the high risk of exposure due to an infection that occurs in the same environment. “
The press release also indicated that the cocktail, a combination of casirivimab and imdevimab known as REGEN-COV, can now be given monthly to people 12 years and older who require repeated dosing with prolonged exposure.
REGEN-COV is not intended to be used as a substitute for a vaccination against COVID-19 and, according to the notification, is not approved for pre-exposure prophylaxis to prevent COVID-19.
“Today’s decision by the FDA to expand the use of REGEN-COV in post-exposure situations is a very helpful step – exposure prophylactic for people with immunodeficiency and for patients admitted to hospital for COVID-19,” said Yancopoulos.
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