17th Dec 2021 14:18
(Alliance News) - GlaxoSmithKline PLC announced on Friday that its Covid-19 treatment, sotrovimab, had been granted marketing authorisation by the European Commission.
The Brentford-based pharmaceutical company said its treatment, developed in partnership with Vir Biotechnology Inc, was approved for use in adults and adolescents aged 12 and over who weigh at least 40 kilograms.
The treatment is for those who do not requite supplemental oxygen and who are at increased risk of progressing to severe Covid-19.
Sotrovimab, also referred to as Xevudy, is a Covid-19 neutralising antibody. It is authorised for emergency use in the US and has conditional marketing authorisation in the UK.
Following the authorisation in the EU, member states participating in the joint procurement agreement can now order the treatment to support their pandemic responses.
GlaxoSmithKline said that authorisation in the EU was based on data from the company's COMET-ICE phase III trial which demonstrated that intravenous treatment with sotrovimab resulted in a 79% reduction in all-cause hospitalisations for more than 24 hours or death due to any cause by day 29 compared to placebo.
In clinical trials conducted to date, sotrovimab had been well-tolerated, the company added. The most common adverse reactions were hypersensitivity and infusion-related reactions. These were seen in approximately 2% and 1% of cases, respectively.
GlaxoSmithKline said that sotrovimab retains activity against all tested variants of concern and interest as defined by the World Health Organization, including Omicron.
Shares in GlaxoSmithKline were down 0.2% at 1,615.40 pence on Friday afternoon in London.
By Heather Rydings; [email protected]
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