December 02, 2021: “GlaxoSmithKline and Vir Biotechnology announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation for Xevudy (sotrovimab) for the treatment of symptomatic adults and adolescents (aged 12 years and over and weighing at least 40 kg) with acute COVID-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID infection.
It is recommended that Xevudy is administered within 5 days of onset of symptoms of COVID-19.
In the coming weeks, UK patients at increased risk of severe complications of COVID-19 will be able to access sotrovimab following a supply agreement reached earlier with the UK government.
The Conditional Marketing Authorisation covers England, Scotland, and Wales. Supply of sotrovimab in Northern Ireland is enabled under the regulation 174 of the Human Medicines Regulations 2012,
George Katzourakis, Senior Vice President, Europe, GSK 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.”
George Scangos, PhD, Chief Executive Officer of Vir, said: “We are pleased with the UK Government’s recognition of the role that monoclonal antibodies, like sotrovimab, have to play in addressing this pandemic.
With clinical data demonstrating a 79% reduction in hospitalisations for more than 24 hours or death in non-hospitalised patients, we are confident sotrovimab will continue to be a critical tool in the fight against COVID-19.
We look forward to making sotrovimab available to the NHS and patients in the UK and to continuing our efforts to increase access worldwide.”
The design of sotrovimab, a monoclonal antibody, is based on the natural antibodies humans already make.
In clinical trials sotrovimab was shown to significantly reduce the risk of hospitalisation or death among high-risk adult outpatients with mild to moderate COVID-19.
The final analysis from the COMET-ICE trial demonstrated a 79% reduction (adjusted relative risk reduction 95% CI, p<0.001; sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) in hospitalisation for more than 24 hours or death due to any cause (by Day 29) compared to placebo.
Sotrovimab has been well tolerated in clinical studies conducted to date. The most common adverse reactions are hypersensitivity reactions, seen in approximately 2% of cases.
GSK and Vir are committed to ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge.
Sotrovimab binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is conserved, which may make it more difficult for resistance to develop.
This indicates potential for sotrovimab to be effective across multiple variants of concern.
Updated in vitro data, published in bioRxiv (the pre-print server for biology) demonstrate that sotrovimab retains activity against all current tested variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organisation (WHO), plus others, including, but not limited to, Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).
Based on the sequence of the Omicron variant, we believe sotrovimab is likely to maintain activity and potency against this variant
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. “
