The United Kingdom has granted Conditional Marketing Authorization for Regeneron Pharmaceuticals Inc.’s (REGN) casirivimab and imdevimab antibody cocktail to prevent and treat acute COVID-19 infection. The cocktail is known as REGEN-COV in the U.S. and Ronapreve in the UK and other countries.<\/p>\n
In addition to the Conditional Marketing Authorization or CMA, which affects people in England, Scotland and Wales, the U.K.’s Medicines and Healthcare products Regulatory Agency or MHRA has also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland.<\/p>\n
As part of the MHRA decisions, 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. <\/p>\n
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.<\/p>\n
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. <\/p>\n
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.<\/p>\n
In the U.S., Regeneron has completed the first FDA BLA submission for the antibody cocktail; more than 130,000 doses were distributed in the past week to address COVID-19 outbreaks.<\/p>\n
The second BLA submission will focus on those hospitalized because of COVID-19, and is expected to be completed later this year. <\/p>\n