UK Authorizes 2nd SARS-CoV-2 Antibody Treatment

Another COVID-19 antibody treatment, Xevudy (sotrovimab), has today been approved by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalization and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.

It is approved for individuals aged 12 and above who weigh more than 40kg.

Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody that works by binding to the spike protein outside the COVID-19 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 hospitalization 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. So the MHRA recommends its use as soon as possible and within five days of symptom onset.

Xevudy (sotrovimab) is the second monoclonal antibody therapeutic approved by the MHRA following Ronapreve (REGEN-COV).

REGEN-COV is delivered via injection or IV, providing 'passive immunity and immediately protecting people from COVID-19. However, it must be re-administered to remain effective over time.

Sotrovimab is administered by intravenous infusion over 30 minutes.

Moreover, it is too early to know whether the Omicron virus variant impacts sotrovimab's effectiveness, but the MHRA is working with the company to clarify this new threat.

Additional antibody treatment news is published on this webpage.