Covid-19: UK approves first monoclonal antibody treatmentBMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n2083 (Published 20 August 2021) Cite this as: BMJ 2021;374:n2083
The UK’s drug regulator has approved the first monoclonal antibody treatment—Ronapreve, a combination of casirivimab and imdevimab—for the treatment and prevention of acute covid-19 in adults.1
The treatment binds to two different sites on the SARS-CoV-2 spike protein, neutralising the virus’s ability to infect cells. It was given the green light after the Medicines and Healthcare Products Regulatory Agency (MHRA) reviewed the available evidence. However, the government and NHS have yet to outline how the treatment will be used in practice.
Japan was the first country to license the treatment in July after a phase III trial reported that casirivimab and imdevimab reduced hospital admission or death by 70% in high risk non-admitted patients. The treatment is administered either by injection or infusion and was found to reduce symptom duration by four days.2
Casirivimab and imdevimab as a combination was also tested as part of the UK’s Recovery trial, which concluded that it reduced the risk of death when given to patients admitted to hospital with severe covid-19 who had not mounted a natural antibody response to the virus.3
Ronapreve has been licensed in the US, India, Switzerland, and Canada, as well as by the European Union.
Samantha Atkinson, MHRA interim chief quality and access officer, said, “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 have conducted a robust and thorough assessment of all the available data.”
Ronapreve was developed by Regeneron and Roche and was notably used to treat the then US president, Donald Trump, in October 2020.
Martin Landray, professor of medicine and epidemiology at the University of Oxford, UK, said that the approval was an important step but that the challenge now was to determine who should receive the treatment.
“Covid-19 is not a rare disease, and many people get better of their own accord after a few days of a nasty flu-like illness,” he said. “It would be hard to justify giving what are likely to be limited supplies of a relatively expensive treatment to huge numbers of people who are likely to get better on their own.
“On the other hand, it may play an important role in patients who are at higher risk of developing severe infection and who are more likely to end up in hospital.”
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