On Aug. 20, 2021, Regeneron announced that the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency had granted Conditional Marketing Authorization (CMA) for the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the UK and other countries, to prevent and treat acute COVID-19 infection. In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland.

As part of the MHRA decisions announced today, the antibody cocktail is authorized 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 authorizations are based on results from two Phase 3 trials evaluating the antibody cocktail to treat high-risk non-hospitalized patients and prevent symptomatic infection in asymptomatic household contacts (both uninfected and infected) of SARS-CoV-2 infected individuals.

The CMA scheme, which covers England, Scotland and Wales, is for products that fulfill an unmet medical need, for example where no satisfactory treatments are available or where the product offers a major therapeutic advantage, and are valid for one year (renewable annually). For people in Northern Ireland, the MHRA emergency supply authorization of the antibody cocktail occurred under regulation 174 of the Human Medicines Regulations 2012, and is valid until expressly withdrawn by the MHRA.

Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., in several European Union countries, India, Switzerland and Canada, and the antibody cocktail is fully approved in Japan. Regeneron invented the antibody cocktail and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the U.S., including throughout the UK. 

In the U.S., REGEN-COV is available for free to eligible people, as part of a U.S. government funded program. REGEN-COV use is increasing across the U.S. following the latest COVID-19 surge, with recent weekly orders surpassing 130,000 doses. In addition to the increasing proportion of patients who now receive REGEN-COV, Regeneron continues to work to ensure all healthcare providers and people who may benefit from this important therapy are aware of its availability.