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First monoclonal antibody treatment for COVID-19 approved for use

The first monoclonal antibody combination drug to prevent and treat serious COVID-19 has been approved for use, based on NIHR-backed research.

The Medicines and Healthcare products Regulatory Agency (MHRA), the government’s independent expert scientific advisory body, has approved Ronapreve.

The drug, developed by Regeneron/Roche, was among treatments studied in the UK-wide, LCRN-supported RECOVERY trial for hospitalised patients.

More than 1,400 patients have taken part in the University of Oxford study in Berkshire, Buckinghamshire, Milton Keynes and Oxfordshire.

The drug is given 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.

Clinical trial data assessed by the MHRA found it may be used to prevent infection, promote resolution of symptoms of acute COVID-19 infection and reduce the likelihood of being admitted to hospital.

The RECOVERY study previously found dexamethasone and tocilizumab are effective at reducing deaths and also ruled out other possible treatments.

Health and Social Care Secretary Sajid Javid said: “This is fantastic news from the independent medicines regulator and means the UK has approved its first therapeutic designed specifically for COVID-19.

“This treatment will be a significant addition to our armoury to tackle COVID-19 – in addition to our world-renowned vaccination programme and life-saving 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.

Read more about the study at gov.uk