The Medicines and Healthcare products Regulatory Agency (MHRA) said, following on from its thorough review of the evidence and the recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body, it has approved Ronapreve for use in the prevention and treatment of acute COVID-19 infection.
Co-developed by Regeneron and Roche, the drug consists of two monoclonal antibodies, casirivimab and imdevimab. It is administered either by injection or infusion and acts at the lining of the respiratory system where it binds tightly to the coronavirus and prevents it from gaining access to the cells of the respiratory system.
The drug is not intended to be used as a substitute for vaccination, the MHRA said.
The MHRA said clinical trial data assessed by its scientists and clinicians has shown that Ronapreve may be used to prevent infection, promote resolution of symptoms of acute COVID-19 infection and can reduce the likelihood of being admitted to hospital due to the coronavirus.
Regeneron/Roche submitted interim clinical trial reports and the MHRA said it expects to receive final study reports in coming months along with the report from the RECOVERY trial conducted by Oxford University.
UK health and social care secretary, Sajid Javid, said the treatment will be a significant addition to the country’s armory to tackle COVID-19 in addition to vaccination and the therapeutics: dexamethasone and tocilizumab. “We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.”
In July, Japan became the first country to approve the use of Ronapreve to treat patients with COVID-19.
Commenting on the development, Prof Penny Ward, independent pharmaceutical physician, visiting professor in pharmaceutical medicine at Kings College, London, said the approval was “very good news”.
“Studies have taught us that when used as a treatment, and provided that it is given as quickly as possible after first symptoms of illness, the treatment can reduce the length of illness and, more importantly, prevent hospitalization and death from COVID in infected people. This is particularly important for people at higher risk of severe disease and dying from COVID, whether or not they have been vaccinated prior to becoming ill.
“The prevention trials showed that giving this antibody to close contacts of individuals sick with COVID can prevent illness and reduce hospitalization and deaths among close contacts, as well as to prevent illness among individuals that are at high risk when given regularly as ‘passive’ prevention over the duration of an outbreak. The antibody treatment will also reduce the viral load produced by people with infection which might reduce the risk of transmission of infection.”
Prof Martin Landray, professor of medicine and epidemiology, Nuffield Department of Population Health, University of Oxford, said:
“This is the monoclonal neutralizing antibody combination initially developed by Regeneron – the one that President Trump received when he had COVID-19 last autumn.
“It combines two antibodies that bind to different places on the coronavirus spike protein, preventing uptake by cells and accelerating clearance of the virus. 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.
“This licensing decision is an important step forward. There have been a number of trials in the out-of-hospital setting, each with positive results – reducing viral clearance and reducing the risk of hospitalization. There have been no major safety concerns.
“The challenge going forward will be in determining which patients should be prioritized for this 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. 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.”