The UK’s drugs authority authorised a novel antibody therapy for Covid-19 on Thursday, believing it will also work against emerging variations like Omicron.
Xevudy or sotrovimab, according to the Medicines and Healthcare Products Regulatory Agency (MHRA), is for persons with mild to moderate Covid-19 who are at high risk of developing severe illness.
Sotrovimab is a single monoclonal antibody developed by GSK and Vir Biotechnology that operates by attaching to the spike protein on the surface of the Covid-19 virus. As a result, the virus is unable to connect to and penetrate human cells, preventing it from replicating in the body.
“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,” said Dr June Raine, MHRA Chief Executive.
“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,” she said.
Sotrovimab is administered by intravenous infusion over 30 minutes and is approved for individuals aged 12 and above who weigh more than 40 kg. The MHRA said “it is too early to know” whether the Omicron variant has any impact on sotrovimab’s effectiveness, but they plan to work with the manufacturers to establish this.
But based on preliminary lab studies, researchers say the drug targets a part of the spike protein of the virus that has not yet undergone big changes or mutations, meaning it should work well against all variants.
A single dosage of the monoclonal antibody was reported to lower the probability of hospitalisation and mortality in high-risk persons with symptomatic Covid-19 infection by 79 percent in a clinical investigation. Sotrovimab is most effective in the early stages of infection, according to clinical trial data, hence the MHRA recommends using it as soon as possible, within five days after symptom start.
“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,” said Professor Sir Munir Pirmohamed, Chair of the UK’s Commission on Human Medicines.
Like molnupiravir, which is an antiviral pill treatment in use, the new therapy 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 risk factors include obesity, older age groups of 60 and above, diabetes mellitus, or heart disease.
The MHRA reiterated that sotrovimab is not intended to be used as a substitute for vaccination against Covid-19. Following the approval, the UK’s National Health Service (NHS) will confirm how this Covid-19 treatment will be deployed to patients.
