Xevudy: Covid treatment which could tackle Omicron variant approved by regulator

A Covid-19 treatment which, the makers say, works against the new Omicron variant has been approved by UK regulators.The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it was giving the green light to Xevudy, a drug developed by GSK and Vir Biotechnology.

Its makers say the drug could tackle the Omicron variant of Covid-19, with preclinical data showing the drug “retains activity against key mutations of the new Omicron Sars-CoV-2 variant”.

The World Health Organization said on Wednesday that the strain had been reported in at least 23 countries around the globe.

The UK has now recorded more than 30 cases of the Omicron variant.

Xevudy works by binding to the spike protein on the outside of the Covid-19 virus, thereby preventing the virus from attaching to and entering human cells, so that it cannot replicate in the body.

In a clinical trial, a single dose of Xevudy was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic Covid.

The drug 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 being aged over-60, obesity, diabetes mellitus or heart disease.

The drug is approved for individuals aged 12 and above who weigh more than 40kg - and the UK government has ordered around 100,000 doses of it.

The drug is the second monoclonal antibody treatment to be approved by the MHRA following Ronapreve.

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The MHRA said it was working with the company to establish effectiveness against Omicron, which has been declared as a variant "of concern" following its rapid spread in South Africa.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."