The US Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ investigational Covid-19 antibody cocktail REGEN-COV.
Designed to block SARS-CoV-2 infectivity, REGEN-COV is a combination of two monoclonal antibodies, casirivimab and imdevimab.
Regeneron and Roche jointly developed the antibody cocktail using Regeneron’s proprietary VelocImmune and VelociSuite technologies.
The latest authorisation enables the therapy to be used for post-exposure prophylaxis in people exposed to Covid-19-infected individuals, or those who are at high risk of being exposed to an infected individual in settings such as nursing homes or prisons.
REGEN-COV was previously authorised in November for emergency use to treat people with mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above.
Regeneron president and chief scientific officer George Yancopoulos said: “Today’s FDA authorization enables certain people at high risk of developing severe COVID-19 infection to access REGEN-COV if they have been exposed to the virus – the first time an antibody treatment has been authorized for this purpose.
“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.”
The company stated that the cocktail can now be administered monthly for individuals who require repeat dosing for ongoing exposure.
The approval is based on data obtained from a pivotal Phase III trial performed to assess the antibody cocktail for post-exposure prophylaxis in people exposed to a Covid-19 patient.
The data showed 81% reduced risk of symptomatic infections in close contacts of SARS-CoV-2 infected individuals.
Regeneron noted that the REGEN-COV is the only Covid-19 antibody therapy that is currently available in the US for both treatment and post-exposure prophylaxis.