The UK regulator, Medicines and Healthcare products Regulatory Agency (MHRA), has authorised Xevudy (sotrovimab) as a covid treatment for people at high risk of developing severe disease.
The new covid treatment has been found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.
Following a thorough review of its safety, quality, and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines have approved this covid treatment, making it the second monoclonal antibody therapeutic to be permitted.
This follows the recent approval of molnupiravir, the first oral covid treatment that works to reduce the risk of hospitalisation and death.
Sotrovimab, new covid treatment for high-risk adults
Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody. The covid treatment works by binding to the spike protein on the outside of the COVID-19 virus. This, in turn, prevents the virus from attaching to and entering human cells, so it cannot replicate in the body.
In the clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection.
Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection. As a result, the MHRA recommends that this type of covid treatment should be used as soon as possible and within five days of symptoms showing.
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.”
Administered by infusion technology
Sotrovimab, similarly to molnupiravir, has been authorised as a new covid treatment for mild to moderate infections. To be eligible for this, one or more risk factors must be present; this includes obesity, diabetes, or heart disease.
However, sotrovimab is administered by intravenous infusion over 30 minutes. It is approved for individuals aged 12 and over who weigh more than 40kg.
The MRHA have not further investigated whether this covid treatment will be effective on omicron due to this new COVID-19 variant being in its early stages. However, they will work with the manufacturer of sotrovimab to establish whether it has any impact on it.
Dr June Raine, MHRA Chief Executive, commented: “I am pleased to say that we now have another safe and effective COVID-19 treatment, Xevudy (sotrovimab), for those at risk of developing severe illness.
“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.
“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data.”