Another COVID-19 treatment, Xevudy (sotrovimab), was approved today by the Medicines and Health Products Regulatory Agency (MHRA) after it was found to be safe and effective in reducing the risk of hospitalization and death in people with mild to moderate COVID. -19 who are at increased risk of developing serious illness.
This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent scientific advisory body, the Commission on Human Medicines, making it the second therapeutic monoclonal antibody to be approved. after Ronapreve.
Developed by GSK and Vir Biotechnology, sotrovimab is a unique monoclonal antibody. The drug works by binding to the spike protein on the outside of the COVID-19 virus. This prevents the virus from attaching itself 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 clinical trial data, sotrovimab is most effective when taken during the early stages of infection and therefore the MHRA recommends its use as soon as possible and within five days of symptom onset.
Like molnupiravir, it has been cleared for use in people who have mild to moderate COVID-19 infection and at least one risk factor for developing serious illness. These risk factors include obesity, old age (> 60 years), diabetes mellitus or heart disease.
Unlike molnupiravir, sotrovimab is given as a 30-minute intravenous infusion. It is approved for people 12 years of age and over weighing over 40 kg.
It is too early to know if the omicron variant has an impact on the effectiveness of sotrovimab, but the MHRA will work with the company to establish it.
Dr June Raine, Executive Director of the MHRA, said:
âI am happy to say that we now have another safe and effective COVID-19 treatment, Xevudy (sotrovimab), for people at risk of developing serious illness.
âThis is another therapy that has been shown to be effective in protecting those most vulnerable to COVID-19, and signals another important step forward in our fight against this devastating disease.
“Without any compromise on quality, safety and efficacy, the public can have confidence that the MHRA has conducted a sound and in-depth assessment of all available data.”
Professor Sir Munir Pirmohamed, Chairman of the Commission on Human Medicines, said:
âThe Commission for Medicinal Products for Human Use and its COVID-19 Therapeutics Expert Working Group have independently reviewed the data and agree with the MHRA’s regulatory approval for Xevudy (sotrovimab).
âWhen given in the early stages of infection, sotrovimab has been shown to be effective in reducing the risk of hospitalization and death in high-risk people with symptomatic COVID-19. Based on the data reviewed by the Commission and its panel of experts, it is clear that sotrovimab is another safe and effective treatment to help us in our fight against COVID-19. “
Sotrovimab is not intended for use as a substitute for vaccination against COVID-19.
The government and the NHS will confirm how this COVID-19 treatment will be rolled out to patients in due course.
Notes to Editors
- The Medicines and Health Products Regulatory Agency is charged with protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK, ensuring that ‘they work and are sufficiently safe. All of our work is backed by solid, fact-based judgments to ensure the benefits justify the risks.
- The MHRA is a center of the Medicines and Health Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Ministry of Health and Social Affairs.
- The Commission for Medicines for Human Use (CHM) advises ministers on the safety, efficacy and quality of medicines. The CHM is a non-ministerial public advisory body sponsored by the Ministry of Health and Social Affairs.
- The MHRA conditional marketing authorization for sotrovimab is only valid in Great Britain. Emergency use authorization has been granted to Northern Ireland to ensure access throughout the UK. Both authorizations were made on the basis of the same rigorous assessment.
- More information can be found in the product information