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December 3, 2021

UK’s MHRA grants authorisation for GSK-Vir Biotechnology’s Covid-19 drug

MHRA has recommended the use of GSK and Vir Biotechnology’s Xevudy within five days from the start of Covid-19 symptoms.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for GSK and Vir Biotechnology’s investigational Covid-19 therapy, Xevudy (sotrovimab).

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The neutralising monoclonal antibody has been authorised to treat symptomatic mild-to-moderate Covid-19 adults and adolescents aged 12 years and above, who are at high risk of developing severe disease.

Prior to granting the authorisation, the MHRA and the Commission on Human Medicines rigorously reviewed the quality, efficacy and safety of the Covid-19 drug.

MHRA’s authorisation was based on the data obtained from the Phase III COMET-ICE trial conducted on 1,057 participants.

It was observed that the drug reduced 79% of hospitalisation and death risk in mild-to-moderate Covid-19 adult patients.

The UK regulator has recommended administering Xevudy (sotrovimab) within five days of Covid-19 symptoms onset in the early stages of infection.

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.”

The authorisation allows the availability of the drug in Wales, England and Scotland.

Incorporating Xencor’s Xtend technology, sotrovimab binds to an epitope on the SARS-CoV-2 virus to delay resistance development.

The antibody can achieve increased concentration in the lungs for penetrating into Covid-19-affected airway tissues and increasing antibody elimination half-life.

Last month, GSK and Vir Biotechnology secured contracts from the US Government to deliver sotrovimab doses for nearly $1bn.

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Free Whitepaper
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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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