Regeneron’s Antibody Cocktail Authorized For Use as Prophylaxis
August 3, 2021
Last Friday, Regeneron announced the FDA’s decision to expand the EUA for their antibody cocktail as a prophylaxis (action taken to prevent disease, especially by specified means or against a specified disease). Previously, it was authorized for non-hospitalized patients aged 12+ who tested positive for a COVID-19 infection and were at risk of experiencing severe disease.
In a Phase 3 trial, the cocktail reduced the risk of symptomatic infection by 81% when used as a post-exposure prophylaxis. This is the first monoclonal antibody treatment that can be used as both a treatment and prophylactic after exposure to COVID-19. The EUA applies to those 12+ who are exposed to someone with the virus, or through certain institutional settings.
“With this authorization, the FDA specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines, who may not mount an adequate response to vaccination, who are exposed to a person with COVID-19 or are in an institutional setting and are at high risk of exposure because of infection occurring in the same setting.” It is estimated that approximately 3% of the U.S. may not respond to the COVID-19 vaccine due to certain health conditions or immunosuppressive therapies.
Regeneron noted the cocktail’s potency against the Delta variant in particular.