UK approves Ronapreve (REGEN-COV) antibodies for COVID-19

• 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 respiratory tract.
• The drug regulator in the United Kingdom has approved Ronapreve, which Regeneron and Roche developed, for both prevention and treatment.
• Research suggests that administering the antibody combo soon after symptoms develop can reduce the chances of hospitalization and death.

The number of people dying with COVID-19 in the U.K. now averages more than 100 a day. According to The Guardian newspaper, this is the highest mortality rate from the disease that the country has seen since March 2021.

The recent resurgence of deaths makes the U.K. drug regulator’s approval of Ronapreve, the first treatment developed specifically for COVID-19, particularly timely.

Despite the U.K. having one of the highest COVID-19 vaccination rates in the world, the highly transmissible Delta variant of the virus has ensured that infection rates remain 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 Healthcare products Regulatory Agency (MHRA) approved Ronapreve on August 20, 2021, to prevent infection, treat the symptoms of severe disease, and reduce the likelihood of hospital admission.

The approval of Ronapreve followed an assessment of clinical trial data by MHRA scientists and clinicians.

The treatment, which healthcare professionals administer by injection or intravenous infusion, comprises two monoclonal antibodies that bind to two different sites on the spike protein that the virus uses to break into its host cells.

This binding prevents the virus from infecting and replicating inside cells that line the respiratory tract.

“[Ronapreve] combines two antibodies that bind to different places on the coronavirus spike protein, preventing uptake by cells and accelerating clearance of the virus,” says Sir Martin Landray, F.Med.Sci., professor of medicine and epidemiology at the University of Oxford in the U.K.

“The rationale for combining two different antibodies is that if a viral variant prevented one drug from binding to the spike protein, the other would still be effective — a ‘belt-and-braces’ approach,” he explains in an expert reaction feature by the Science Media Centre in London.

Trial data suggest that the combination not only reduces hospitalization and death when a person starts taking it within 3 days of a positive PCR test but also prevents illness in close contacts of individuals with the infection.

Prof. Landray is a co-lead of the RECOVERY clinical trial, which is investigating treatments for people in the hospital with COVID-19 and has 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 were not producing their own antibodies against the virus.

Doctors successfully used Ronapreve to treat the former U.S. president, Donald Trump, during his hospitalization with COVID-19 in the fall of 2020.

Reduced viral load

Penny Ward, an independent pharmaceutical physician and visiting professor in pharmaceutical medicine at King’s College London, said that Ronapreve reduces the viral load in people with the infection, which may help prevent transmission.

She told the SMC that, following its approval in the U.K., healthcare professionals may target the treatment at individuals who are vulnerable to severe infection.

“I think it is most likely to be used to prevent hospitalization among people becoming sick with COVID who are at higher risk of needing hospital care/dying from disease,” she said.

She added that the treatment might also be useful for preventing infection in people with a poor immune response to vaccination — for example, as a result of cancer treatment or taking immunosuppressants following a transplant.

The MHRA stressed that it did not see the treatment as a substitute for vaccination, however.

It is worth noting that Regeneron and Roche conducted their clinical trials of 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 U.S., have given Ronapreve emergency approval to treat COVID-19.

In November 2020, the U.S. authorized 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 licensed 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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