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GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.
GlaxoSmithKline (GSK) and Vir Biotechnology announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Xevudy (sotrovimab) for treating symptomatic adults and adolescents (aged 12 years and older, weighing at least 40 kg) with acute COVID-19 infection. The treatment is for patients who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID infection.
According to a Dec. 2, 2021, company press release, the recommended use of Xevudy is to administer it within five days of the onset of COVID-19 symptoms. UK patients at increased risk of severe complications of COVID-19 will soon be able to access sotrovimab following a supply agreement reached earlier with the UK government.
This conditional marketing authorization covers England, Scotland, and Wales. Supply of treatment in Northern Ireland is enabled under regulation 174 of the Human Medicines Regulations 2012, according to the press release.
Clinical trials have shown that sotrovimab significantly reduces the risk of hospitalization or death among high-risk adult outpatients with mild to moderate COVID-19. There was a 79% reduction in hospitalization 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, and the most common adverse reactions were hypersensitivity reactions (approximately 2% of cases).
“The conditional marketing authorization in Great Britain, coupled with the supply agreement, is a testament to the critical need to make sotrovimab available in the [United Kingdom] 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,” said George Katzourakis, senior vice-president, Europe, GSK, in the press release.
“We are pleased with the UK Government’s recognition of the role that monoclonal antibodies, [such as] sotrovimab, have to play in addressing this pandemic. With clinical data demonstrating a 79% reduction in hospitalizations for more than 24 hours or death in non-hospitalized 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 [National Health Service] and patients in the UK and to continuing our efforts to increase access worldwide,” said George Scangos, CEO of Vir, in the press release.