GSK and Vir Biotechnology announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Xevudy (sotrovimab), their Covid-19 treatment.
Sotrovimab was indicated for treating Covid-19 in symptomatic adults and adolescents, aged 12 years and above, who are at elevated risk of severe disease.
The conditional marketing authorisation (CMA) recommends the administration of the drug within five days of onset of Covid-19 symptoms and covers England, Scotland, and Wales.
GSK and Vir have previously reached a supply agreement with the UK government.
With the regulatory approval, high-risk Covid-19 patients in the UK can access sotrovimab.
GSK Europe senior vice president George Katzourakis said: “The conditional marketing authorisation in Great Britain, coupled with the supply agreement, is a testament to the critical need to make sotrovimab available in the UK as the pandemic continues to progress.
“We believe it is important to ensure that we have treatments ready and available, especially early treatment options, for a broad group of patients at increased risk of progressing to severe Covid-19.”
Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody, jointly developed by GSK and Vir, under a partnership started in April last year.
The collaboration is structured to leverage Vir’s monoclonal antibody platform technology, and GSK’s expertise in functional genomics.
Also, it combines the companies’ CRISPR screening and artificial intelligence (AI) capabilities to identify anti-coronavirus compounds that target cellular host genes.
The MHRA approval was based on data from Phase 3 clinical trials, in which sotrovimab significantly reduce the risk of hospitalisation or death among high-risk Covid-19 patients.
In the analysis from the COMET-ICE trial, the drug showed a 79% reduction in hospitalisation for more than 24 hours or death due to any cause, compared to placebo.
Sotrovimab was well tolerated in clinical studies, with the most common adverse reactions include hypersensitivity reactions.
In a separate development, GSK and Vir’s sotrovimab showed activity against mutations of the new Omicron variant (B.1.1.529), according to preclinical data published in bioRxiv.
The data was collected through pseudo-virus testing of specific mutations found in Omicron.
GSK and Vir are continuing the testing to validate the neutralising activity of sotrovimab against all the Omicron mutations, to provide the results by the end of this year.
According to the companies, sotrovimab is showing ongoing activity against the combination of all tested variants of concern and interest, to date.
