UK drug regulator approves GSK COVID-19 treatment

UK drug regulator approves GSK COVID-19 treatment
GSK/Vir Biotechnology
Thursday 2 December 2021 - 15:33

The UK Medicines and Healthcare products Regulatory Agency (MHRA) gave the green light on Thursday to the use of sotrovimab, a COVID-19 monoclonal treatment which its manufacturer, the London-based multinational pharmaceutical company GlaxoSmithKline (GSK), said “retains activity” against the Omicron variant of the coronavirus.

“I am pleased to say that we now have another safe and effective COVID-19 treatment, Xevudy (sotrovimab), for those at risk of developing severe illness,” MHRA chief executive June Raine said in a statement.

The UK regulator said that a clinical trial showed that the single monoclonal antibody can reduce the risk of hospitalization and death by 79% in high-risk COVID-19 patients.

Last month, the UK regulator approved an oral antiviral developed by US pharmaceutical Merck, but unlike molnupiravir, the GSK treatment is administered by intravenous infusion over 30 minutes and has been approved for individuals aged 12 and above who weigh more than 40 kilograms (88 lb).

In a separate statement, GSK said sotrovimab has shown ongoing activity against all tested variants of concern and defined by the World Health Organization, including Omicron, which was identified in South Africa last week.

Nine further cases of the Omicron variant were identified in England on Wednesday, taking the UK’s total to 32.

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