It has been announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has given approval for the first monoclonal antibody treatment for the prevention and treatment of acute COVID-19 in the UK.
Prof Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, said:
“This is the monoclonal neutralising 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 hospitalisation. There have been no major safety concerns.
“The challenge going forward will be in determining which patients should be prioritised for this treatment. COVID 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.
“(Note: The treatment has also been studied in patients who have already been admitted to hospital: In the RECOVERY trial involving over 9000 patients admitted with COVID-19 we found that the treatment was effective in reducing the risk of death and shortening hospital stay for those patients who had not mounted their own natural antibody response to the virus. However, today’s news does not relate to the use of this treatment in that context.)”
Dr Penny Ward: “No COIs. I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody). These are my personal views and do not reflect those of either institution.”
Prof Martin Landray: “Co-lead, RECOVERY trial of treatments for patients hospitalised with COVID-19. Note: Regeneron provided supplies of the monoclonal antibody combination for evaluation in the RECOVERY trial. Roche provided supplies of tocilizumab, another drug which we evaluated in the RECOVERY trial.”
None others received.