MHRA approves Xevudy (sotrovimab) to treat COVID-19

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Xevudy (sotrovimab) for people aged 12 and above who weigh more than 40kg and who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness, such as obesity, older age, diabetes mellitus, or heart disease.

The approval follows a rigorous 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, making it the second monoclonal antibody therapeutic to be approved following Ronapreve.

Developed by GlaxoSmithKline (GSK) and Vir Biotechnology, sotrovimab is a single monoclonal antibody. The drug works by binding to the spike (S) protein on the outside of 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. Sotrovimab is administered by intravenous infusion over 30 minutes. 

In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalisation and death by 79 percent 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. Consequently, the MHRA recommends its use as soon as possible and within five days of symptom onset.

The MHRA added that it is too early to know whether the omicron variant has any impact on sotrovimab’s effectiveness but the MHRA will work with the company to establish this.

“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,” stated MHRA Chief Executive Dr June Raine. “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.”

“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,” added Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines. “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.”