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- Ronapreve, known as REGEN-COV in the United States, is a combination of two monoclonal antibodies that bind to SARS-CoV-2, the virus that causes COVID-19.
- This binding prevents the virus from infecting cells in the lining of the airways.
- The UK drug regulator has approved Ronapreve, developed by Regeneron and Roche, for both prevention and treatment.
- Research suggests that administering the antibody combo soon after symptoms appear may reduce the risk of hospitalization and death.
The number of people who have died from COVID-19 in the UK is now on average over 100 per day. According to The Guardian newspaper, it is the highest death rate from the disease the country has seen since March 2021.
The recent resurgence of deaths makes the UK regulator’s approval of the drugs Ronapreve, the first treatment developed specifically for COVID-19, particularly timely.
Although the UK has one of the highest COVID-19 vaccination rates in the world, the highly transmissible Delta variant of the virus has kept infection rates high.
Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.
The Medicines and Health Products Regulatory Agency (MHRA) approved Ronapreve on August 20, 2021 to prevent infections, treat symptoms of serious illness, and reduce the likelihood of hospitalization.
Ronapreve’s approval follows an evaluation of clinical trial data by scientists and clinicians at the MHRA.
Treatment, which healthcare professionals give by injection or intravenous infusion, includes two monoclonal antibodies that bind to two different sites on the spike protein that the virus uses to enter its host cells.
This binding prevents the virus from infecting and replicating inside the cells that line the airways.
“[Ronapreve] combines two antibodies that bind to different places on the coronavirus spike protein, preventing uptake by cells and accelerating virus elimination, ”says Sir Martin Landray, F.Med.Sci., professor of medicine and epidemiology at the University of Oxford in the United Kingdom
“The rationale for combining two different antibodies is that if one viral variant prevented one drug from binding to the spike protein, the other would still be effective – a ‘belt and suspenders’ approach,” he explains in an expert response article by the Science Media Center in London.
Data from the trials suggest that the combination not only reduces hospitalizations and deaths when a person starts taking it within 3 days of a positive PCR test, but also prevents illness in close contacts of those infected.
Professor Landray is co-leader of the RECOVERY clinical trial, which studies treatments for hospitalized people with COVID-19 and evaluated the use of Ronapreve in this context.
The trial found that the treatment reduced the risk of death and shortened hospital stays for people who did not produce their own antibodies to the virus.
Doctors have successfully used Ronapreve to treat former US President Donald Trump while hospitalized with COVID-19 in the fall of 2020.
Penny Ward, independent pharmaceutical doctor and visiting professor of pharmaceutical medicine at King’s College London, said Ronapreve lowers the viral load in those infected, which may help prevent transmission.
She told the MSC that following its approval in the UK, healthcare professionals could target treatment to people at risk of serious infection.
“I think it’s most likely to be used to prevent hospitalization in people who get sick with COVID and who are at a higher risk of needing hospital care / dying from the disease,” said she declared.
She added that the treatment could also be helpful in preventing infection in people with a weak immune response to vaccination, for example following cancer treatment or taking immunosuppressants after a transplant.
The MHRA stressed, however, that it did not view the treatment as a substitute for vaccination.
It should be noted that Regeneron and Roche conducted their clinical trials with Ronapreve before the emergence of “variants of concern”, such as the Delta variant of SARS-CoV-2.
Regulatory authorities in more than 20 countries, including the United States, have granted Ronapreve emergency clearance to deal with COVID-19.
In November 2020, the United States cleared another monoclonal antibody treatment, bamlanivimab, which Eli Lilly developed for people with mild or moderately severe COVID-19.
In addition to Ronapreve, the MHRA has cleared two other proven treatments for the disease that were originally developed for other purposes: the steroid dexamethasone and the arthritis drug tocilizumab.
The latter is a monoclonal antibody that binds to IL-6, which is an immune signaling protein, or “cytokine,” that promotes inflammation.
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