The UK drugs watchdog has approved a new Covid treatment after trials found it cut the likelihood of hospital admission and death by 79% in high-risk adults.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Xevudy (sotrovimab), a monoclonal antibody made by GlaxoSmithKline (GSK) and Vir Biotechnology, for people with mild to moderate Covid-19 at high risk of developing severe disease.
GSK and Vir Biotechnology said preclinical data showed the drug “retains activity against key mutations of the new Omicron Sars-CoV-2 variant”.
The UK government has ordered about 100,000 doses of the drug. It is the second monoclonal antibody treatment to be approved by the MHRA following Ronapreve.
Dr June Raine, the 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.”
The drug works by binding to the spike protein on the outside of the coronavirus. This in turn prevents the virus from attaching to and entering human cells, so it cannot replicate in the body.
Based on trial data, the drug is most effective when taken during the early stages of infection. As a result, the MHRA said it should be given as soon as possible and within five days of symptoms starting.
The drug has been approved for people who have mild to moderate Covid-19 infection and at least one risk factor for developing severe illness. These include obesity, being 60 or over, diabetes or heart disease.
Xevudy is administered by intravenous infusion over 30 minutes and is approved for people aged 12 and over. The MHRA said it was working with the company to establish effectiveness against the new Omicron variant.
George Scangos, the chief executive of Vir, said: “Sotrovimab was deliberately designed with a mutating virus in mind.
“This hypothesis has borne out again and again, with its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations found in Omicron, as demonstrated by preclinical data.”
The news came after ministers secured 114m more Covid-19 vaccines from Pfizer and Moderna for potential booster campaigns in the next two years.
The boss of Pfizer said annual vaccines to tackle Covid-19 were likely to be needed. Dr Albert Bourla said yearly vaccinations could boost population immunity, adding that the company was already working on a new jab for the Omicron variant.
He told the BBC: “Based on everything I have seen so far, I would say that annual vaccinations … are likely to be needed to maintain a very robust and very high level of protection.”
Bourla also said vaccines had helped save millions of lives during the pandemic, and without them the “fundamental structure of our society would be threatened”.