The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised Regeneron/Roche’s antibody cocktail for the treatment and prevention of COVID-19.
The conditional marketing authorisation (CMA) for Ronapreve – a combination of monoclonal antibodies casirivimab and imdevimab (known as REGEN-COV in the US) – means patients across all four nations of the UK can receive the treatment.
The combination therapy is authorised to treat and prevent COVID-19 including in people who may need ongoing monthly doses if they have a medical condition that makes them unlikely to respond to or be protected by vaccination.
UK health and social care secretary, Sajid Javid, said: “The UK is considered a world leader in identifying and rolling out life-saving treatments for COVID-19, once they have been proven safe and effective in our government-backed clinical trials. This treatment will be a significant addition to our armoury to tackle COVID-19.”
He added that the UK government was “working at pace” with the NHS and clinicians to ensure Ronapreve is rolled out to NHS patients quickly.
MHRA interim chief quality and access officer Samantha Atkinson added: “Ronapreve is the first of its kind for the treatment of COVID-19, and after a meticulous assessment of the data by our expert scientists and clinicians, we are satisfied that this treatment is safe and effective. With no compromises on quality, safety and efficacy, the public can trust that the MHRA has conducted a robust and thorough assessment of all the available data.”
In the US, the casirivimab/imdevimab combination is available without charge to eligible people as part of a government-funded programme. Regeneron reports that weekly orders recently surpassed 130,000 doses after the latest surge in the virus.
Earlier this month, the company submitted the first of two biologics licence applications (BLAs) for REGEN-COV. The initial submission included data on the treatment and prevention of SARS-CoV-2 infection in non-hospitalised people, while the second BLA will focus on those hospitalised with COVID-19.
Recent research also shows that the antibody cocktail is effective against the main variants of concern circulating in the US and other countries, including the Delta, Gamma and Beta variants.
While the casirivimab/imdevimab combination is available in more than 20 countries under emergency or temporary pandemic use authorisations, the only country to have officially approved the antibody cocktail is Japan.
“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,” said George Yancopoulos, president and chief scientific officer at Regeneron. “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.”
Yancopoulos added that the company was in discussions with authorities in France and “other regulatory authorities” including the FDA.
Casirivimab and imdevimab are potent, virus-neutralising antibodies that bind non-competitively to the critical receptor binding domain of the virus’s spike protein. By doing so, the drugs reduce the ability of mutant viruses to escape treatment and protect against spike variants that have arisen in the human population.