Omicron: Commuters have their say over coronavirus measures
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The monoclonal antibody sotrovimab, known as Xevudy, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for people in the UK at high risk of developing severe COVID-19. It has been made by GlaxoSmithKline (GSK) and can cut the risk of infection requiring hospitalisation or death by 79 percent. In a statement, the company said: “In a 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 and so the MHRA recommends its use as soon as possible and within five days of symptom onset.”
The wonder-drug was developed by experts from GSK and Vir Biotechnology.
It works by binding to the spike protein on the outside of the COVID-19 virus.
This prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.
It has been authorised for people with Covid who have at least one risk factor which might cause them to develop serious illness – like age, obesity, heart disease and diabetes.
Dr June Raine, MHRA Chief Executive said: “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.”
Its 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.
It becomes the second monoclonal antibody therapeutic to be approved following Ronapreve.
Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of symptom onset.
Like molnupiravir, it 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.
But unlike the wonder-pill, sotrovimab is administered by intravenous infusion over 30 minutes.
It is approved for individuals aged 12 and above who weigh more than 40kg.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and agrees with the MHRA’s regulatory approval of Xevudy.
“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.”
It is important to point out that the drug is not intended to be used as a substitute for vaccination against COVID-19.
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