New COVID-19 treatment found to cut risk of death by 79% approved in UK
Xevudy has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
It’s been announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new COVID-19 treatment for use in the UK.
Following 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, the treatment was found to successfully reduce the risk of hospitalisation and death in people with mild to moderate COVID-19 infection, who are at an increased risk of developing severe disease.
The treatment – known as Xevudy (sotrovimab) – has been developed by GSK and Vir Biotechnology, and is a single monoclonal antibody that, according to a statement published by the UK government website, works by binding to the spike 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.
Xevudy is the second monoclonal antibody therapeutic to be approved, following Ronapreve.
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, and based on the clinical trial data, the government says sotrovimab is most effective when taken during the early stages of infection.
And so, the MHRA has said it recommends its use as soon as possible and within five days of symptom onset.
The approval for use of this treatment follows the confirmation that the first pill to treat symptomatic COVID-19 – molnupiravir – has also been approved for use in the UK back at the start of November.
Like molnupiravir, Xevudy 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 as obesity, older age (+60 years), diabetes mellitus, or heart disease – but unlike molnupiravir, sotrovimab is administered by intravenous infusion over 30 minutes, and it has also been approved for individuals aged 12 and above who weigh more than 40kg.
The MHRA says it’s too early to know whether the Omicron variant has any impact on sotrovimab’s effectiveness, but the body 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,” announced Dr June Raine, Chief Executive of the MHRA.
“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.”
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