The MHRA approved the monoclonal antibody treatment sotrovimab, after trials found it reduced risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection.
The drug is the second approved in the UK to treat COVID-19 - after the MHRA approved the antiviral molnupiravir (Lagevrio) in early November.
Unlike molnupiravir, which is taken orally, sotrovimab - also known as Xevudy - is administered by intravenous infusion over 30 minutes. It has been approved for individuals aged 12 and above who weigh more than 40kg.
Regulators have said it is ‘too early’ to know whether the Omicron variant has any impact on sotrovimab’s effectiveness - and have stressed it is not intended to be used as a substitute for COVID-19 vaccination.
COVID-19 treatment
Sotrovimab has been authorised for use in people who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness, such as obesity, diabetes, heart disease or age over 55.
Clinical trials found the treatment is most effective when taken in the early stages of infection and the MHRA advises it is used ‘as soon as possible and within five days of symptom onset’. The regulator said the government and NHS would confirm in 'due course' how the treatment will be deployed.
MHRA chief executive Dr June Raine, 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.’
Chair of the Commission on Human Medicines Professor Sir Munir Pirmohamed, 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. [It is] another safe and effective treatment to help us in our fight against COVID-19.’
The first drug treatment against coronavirus was approved earlier this month and is recommended for use on people who contract COVID and suffer with obesity, diabetes, heart disease, or that are 60 years and older.
