The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Conditional Marketing Authorisation (CMA) to Regeneron for the casirivimab and imdevimab antibody cocktail to prevent and treat acute COVID-19 infection.
In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA has also authorised emergency supply of the antibody cocktail – known as REGEN-COV in the US and Ronapreve in the UK and other countries – to prevent and treat acute COVID-19 infection for people in Northern Ireland.
“In addition to preventing hospitalisation and death in patients already infected with the virus, we are encouraged that governments recognise the benefits of REGEN-COV in preventing infection in the first place, including in immunocompromised people who may not respond to vaccines due to an underlying medical condition, or medicines used to treat an underlying condition,” said George D. Yancopoulos, President and Chief Scientific Officer of Regeneron.
“This indication is now authorised in the UK and available under early access authorisation in France, and we are in ongoing discussions with other regulatory authorities, including the US FDA, to help bring REGEN-COV prevention to the many at-risk immunocompromised individuals who are not sufficiently protected by vaccination.”
As part of the MHRA decisions, the antibody cocktail is authorised to treat people across the UK who have an existing infection or to prevent COVID-19 infection, including among people who may need ongoing monthly doses if they have a medical condition making them unlikely to respond to or be protected by vaccination.
The MHRA authorisations are based on results from two Phase 3 trials evaluating the antibody cocktail to treat high-risk non-hospitalised patients and prevent symptomatic infection in asymptomatic household contacts (both uninfected and infected) of SARS-CoV-2 infected individuals.