Green light from medicines regulator comes as pharmaceutical giant says lab results show ‘activity against key mutations of Omicron’.
The United Kingdom has approved the use of a drug to treat people at high risk of developing severe COVID-19 symptoms, which the manufacturers say appears to be effective against the new Omicron variant.
The antibody treatment, sotrovimab, “was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease”, the Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement on Thursday.
A single dose of the drug was found to reduce the risk of hospitalisation and death by 79 percent in high-risk adults with symptomatic COVID-19, according to the regulator.
Following its review, the MHRA recommended sotrovimab, also known under the brand name Xevudy, be used as soon as possible and within five days of the onset of symptoms.
June Raine, the MHRA’s chief executive, welcomed its addition to the UK’s arsenal for battling the coronavirus pandemic as “yet another therapeutic that has been shown to be effective at protecting those most vulnerable to COVID-19”.
Last month, the UK became the first country to approve molnupiravir, a potentially game-changing COVID-19 antiviral pill jointly developed by Merck and Ridgeback Biotherapeutics.
Sotrovimab was developed by GlaxoSmithKline (GSK), a UK-based company, and the US-headquartered Vir Biotechnology.
It is a monoclonal antibody, a type of protein that attaches to the spike protein of the coronavirus, reducing its ability to enter the body’s cells.
GSK said on Thursday that lab analysis showed the drug is effective against viruses that were bio-engineered to carry a number of hallmark mutations of the Omicron variant, which is more heavily mutated than previous strains of the coronavirus.
Preclinical data showed that the drug “retains activity against key mutations of the new Omicron SARS-CoV-2 variant,” the pharmaceutical giant said in a statement.
Tests are ongoing to confirm the results against all of the Omicron mutations with an update expected by year-end, it added.
GSK said sotrovimab had also demonstrated “ongoing activity” against all other tested variants of concern and interest identified by the World Health Organization, including the highly transmissible Delta strain which has fuelled a surge in cases in many parts of Europe, the current epicentre of the pandemic, in recent months.
Treatments to tackle the global health crisis, which has killed more than five million people worldwide, have so far focused mainly on vaccines.
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