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MHRA approves second COVID-19 antibody treatment

Preclinical data for GSK and Vir’s Xevudy suggests it retains activity against Omicron and all other variants of concern

MHRA

The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has approved a second antibody treatment against COVID-19.

Like Regeneron/Roche antibody cocktail Ronapreve (casirivimab/imdevimab), known as REGEN-COV in the US, Xevudy (sotrovimab) is licensed to treat people with mild to moderate COVID-19 who have at least one risk factor for developing severe disease.

Risk factors include obesity, older age (>55 years), diabetes mellitus and heart disease.

Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody that binds to the spike protein of the virus preventing it from replicating in the body.

In trials, a single dose of Xevudy reduced the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection.

The antibody, which is administered by intravenous infusion over 30 minutes, is approved for individuals aged 12 and above who weigh more than 40kg. As the treatment works best in the early stages of infection, the treatment should be administered as soon as possible and must be within five days of symptom onset.

Dr June Raine, chief executive of the MHRA, called Xevudy “another safe and effective COVID-19 treatment”, stating that its approval “signals another significant step forward in our fight against this devastating disease”.

The approval coincides with new preclinical data released by GSK and Vir suggesting that Xevudy retains activity against key mutations of the new Omicron variant of concern, including those found in its binding site.

While company said the data will need to be confirmed by ‘further in vitro pseudo-virus testing’, Xevudy had now ‘demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization’.

“Sotrovimab was deliberately designed with a mutating virus in mind,” said Vir CEO, George Scangos. “By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable.

“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. We have every expectation that this positive trend will continue and are working rapidly to confirm its activity against the full combination sequence of Omicron,” said Scangos.

Only two weeks ago, GSK and Vir announced that it had signed purchase agreement worth around $1bn with the US government for Xevudy, bringing the total number of doses sold to more than 750,000 globally.

Article by
Hugh Gosling

3rd December 2021

From: Regulatory

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