The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Conditional Marketing Authorization (CMA) for Regeneron’s antibody cocktail to treat and prevent acute COVID-19 infection.
Regeneron Pharmaceuticals has announced that the United Kingdom’s MHRA has authorised casirivimab and imdevimab antibody cocktail, branded as REGEN-COV™ in the U.S. and Ronapreve® in the UK and other countries, for the prevention and treatment of acute COVID-19 infection.
Antibody Cocktail marketed as Ronapreve® in the UK to be rolled out on the NHS
In addition to the CMA, which covers people in England, Scotland and Wales, the MHRA has also authorised an emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland. The UK’s Chief Medical Officers are expected to confirm how the antibody cocktail will be rolled out on the National Health Service (NHS) in the weeks to come.
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron stated:
“Despite the remarkable collective efforts of governments, healthcare professionals and communities across the globe, COVID-19 continues to cause significant illness and death, with new variants making the fight even more challenging. In addition to preventing hospitalization and death in patients already infected with the virus, we are encouraged that governments recognize 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. This indication is now authorized in the UK and available under early access authorization in France, and we are in ongoing discussions with other regulatory authorities, including the U.S. 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 announced MHRA decisions, the antibody cocktail is authorised to treat people in the UK who have an existing infection or to prevent COVID-19 infection, including for people who may need continuous monthly doses if they have a medical condition making them less likely to respond to or be protected through vaccination.
The MHRA authorisations are based on results from two Phase 3 clinical trials assessing 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 is for products that fulfill an unmet medical need, such as where no satisfactory treatments are available or where the product offers a significant therapeutic advantage, and are valid for one year pending annual renewal. 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.
Roche primarily responsible for development and distribution of Ronapreve® (casirivimab and imdevimab) in the UK
Emergency or temporary pandemic use authorisations are now 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 developed the antibody cocktail and is collaborating with Roche to boost 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. Following the recent
COVID-19 surge the use of REGEN-COV is increasing across the U.S. with weekly orders surpassing 130,000 doses. In addition to the rising number of patients who now receive REGEN-COV, Regeneron continues to work to ensure all healthcare providers and individuals who may benefit from this innovative therapy are aware of its availability.
Earlier this month Regeneron submitted the first of two Biologics License Applications (BLAs) for REGEN-COV. The initial submission included data on the efficacy and safety of REGEN-COV to treat and prevent SARS-CoV-2 infection in non-hospitalized people. The second BLA submission will center on those hospitalized because of COVID-19, and is anticipated to be completed later this year.
Antibody cocktail retains potency against the main new variants
Multiple analyses, including a recent publication in Cell, have shown that the antibody cocktail retains potency against the main new variants of concern circulating in the U.K., the U.S. and other countries, including Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in Brazil) and Beta (B.1.351; first identified in South Africa). This is why, REGEN-COV remains available for use across the U.S., and Regeneron plans to continue to actively monitor the potency of REGEN-COV against emerging COVID-19 variants.
The development and production of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was developed specifically to block the infectivity of SARS-CoV-2, utilising Regeneron’s proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.
The robust REGEN-COV development program has reported positive Phase 3 trial results across the spectrum of COVID-19 infection, from prevention to hospitalization:
- Prevention of symptomatic infection in asymptomatic household contacts (both uninfected and infected) of SARS-CoV-2 infected individuals
- Treatment of non-hospitalized patients already infected with SARS-CoV-2
- Treatment of certain patients hospitalized due to COVID-19 infection, including the UK RECOVERY trial
In the UK, Ronapreve is subject to additional monitoring as part of the MHRA authorization and adverse events should be reported.
Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).