The treatment, Xevudy (sotrovimab), was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate infection following a review.
The drug works by binding to the spike protein on the outside of the virus. This in turn prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.
In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalisation and death by 79 per cent in high-risk adults with symptomatic Covid infection.
Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of symptom onset.
Preclinical trial data from GSK suggests the treatment retains efficacy against key mutations found in the Omicron variant.
Dr June Raine, MHRA Chief Executive said: “This is yet another therapeutic that has been shown to be effective at protecting those most vulnerable to Covid-19, and signals another significant step forward in our fight against this devastating disease.”
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “When administered in the early stages of infection, sotrovimab was found to be effective at reducing the risk of hospitalisation and death in high-risk individuals with symptomatic Covid-19.
“Based on the data reviewed by the Commission and its expert group, it is clear sotrovimab is another safe and effective treatment to help us in our fight against Covid-19.”
The treatment is administered by intravenous infusion over 30 minutes, and can be used in individuals aged 12 and over.
The government and the NHS will lay out plans on how the treatment will be deployed to patients in due course.