British drug watchdog approves new Covid Xevudy treatment

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Britain’s medicines watchdog has approved a new Covid treatment after trials found it reduced the likelihood of hospitalization and death by 79% in high-risk adults.

The Medicines and Health Products Regulatory Agency (MHRA) has cleared 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 serious illness.

GSK and Vir Biotechnology said preclinical data showed the drug “retains activity against key mutations in the new variant Omicron Sars-CoV-2”.

The UK government has ordered around 100,000 doses of the drug. This is the second monoclonal antibody treatment to be approved by the MHRA after Ronapreve.

Dr June Raine, Managing Director of MHRA, said: “I 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.

“This 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. “

The drug works by binding to the spike protein on the outside of the coronavirus. This prevents the virus from attaching itself and entering human cells so that 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 administered as soon as possible and within five days of the onset of symptoms.

The drug has been approved for people who have a mild to moderate Covid-19 infection and at least one risk factor for developing serious illness. These include obesity, being 60 years of age or older, diabetes, or heart disease.

Xevudy is administered by intravenous infusion over 30 minutes and is approved for persons 12 years of age and older. The MHRA said it is working with the company to establish efficacy against the new Omicron variant.

George Scangos, CEO of Vir, said: “Sotrovimab was deliberately designed with a mutant virus in mind.

“This hypothesis has been confirmed time and time again, with its continued ability to maintain activity against all of the variants tested of concern and interest to date, including key mutations found in Omicron, as evidenced by preclinical data. “

The news came after ministers secured an additional 114 million Covid-19 vaccines from Pfizer and Moderna for potential recall campaigns over the next two years.

The Pfizer boss said annual vaccines to fight Covid-19 would likely be needed. Dr Albert Bourla said annual vaccinations could boost the immunity of the population, adding that the company was already working on a new vaccine for the Omicron variant.

He told the BBC: “Based on everything I’ve seen so far, I would say that annual vaccinations… will probably be necessary to maintain a very robust and very high level of protection. ”

Bourla also said that vaccines have helped save millions of lives during the pandemic, and without them “the basic structure of our society would be at risk.”

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