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UK authorisation has been given for sotrovimab for patients with mild to moderate COVID-19 who are at risk of developing severe disease.
The Medicines and Healthcare products Regulatory Agency (MHRA) said that the single monoclonal antibody drug was a safe and effective treatment for reducing the risk of hospitalisation and death.
Results from a clinical trial, published as a preprint last month, suggested that a single dose of sotrovimab (Xevudy, GSK and Vir Biotechnology) reduced the risk of hospitalisation in high-risk adults for longer than 24 hours, or death within 29 days, by 79% (95% CI 50% to 91%) compared to placebo.
Sotrovimab works by binding to the spike protein on the outside of the COVID-19 virus to prevent it from attaching to and entering human cells.
The treatment is administered by intravenous infusion over 30 minutes and has been approved for people aged 12 and older who weigh more than 40 kg.
The MHRA said it recommended treatment within 5 days of the onset of symptoms as the drug was most effective when given in the early stages of infection.
Trials Testing Effectiveness Against OMICRON Variant
It said it was too early to know whether the Omicron variant of the SARS-CoV-2 virus would have any impact on efficacy.
However, in a statement for the media and investors, GSK said preclinical data suggested that the drug retained activity against key mutations of Omicron because it targeted a conserved region of the spike protein that was less likely to mutate. It said further testing was underway to demonstrate effectiveness against the variant.
George Scangos, chief executive officer of Vir Biotechnology, said: “Sotrovimab was deliberately designed with a mutating virus in mind.”
Approval followed “a rigorous review of its safety, quality, and effectiveness by the UK regulator and the Government’s independent expert scientific advisory body, the Commission on Human Medicines”, the MHRA said.
Sotrovimab is the second monoclonal antibody therapy to be given the green light following approval of combination treatment casirivimab and imdevimab (Ronapreve, Regeneron Pharmaceuticals) in August.
Earlier this week, Regeneron announced it was evaluating the effectiveness of Ronapreve – also known as REGEN-COV – against the Omicron variant.
‘Another Step Forward’
Dr June Raine, MHRA chief executive said that sotrovimab was “yet another therapeutic that has been shown to be effective at protecting those most vulnerable to COVID-19, and signals another significant step forward in our fight against this devastating disease”.
She said there had been “no compromises on quality, safety, and effectiveness”.
The Government and the NHS will confirm how this COVID-19 treatment will be deployed to patients in due course, the MHRA said.
Créditos: Comité científico Covid