A new Covid-19 treatment has been approved by UK regulators, in what could be a major boost for the NHS ahead of a difficult winter.
The monoclonal antibody Xevudy (sotrovimab), made by GlaxoSmithKline (GSK), has been approved for people in the UK at high risk of developing severe Covid-19, the Medicines and Healthcare products Regulatory Agency (MHRA) said.
The treatment has been found to cut hospitalisation and death by nearly 80% and will be given to people with mild to moderate Covid-19 who are at high risk of going on to develop severe disease.
MHRA chief executive Dr June Raine explained: ‘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.
‘This is 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.
‘With no compromises on quality, safety and effectiveness, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data.’
The drug works by binding to the spike protein on the outside of the virus.
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That prevents the virus from attaching to and entering human cells, meaning it cannot replicate in the body.
Clinical trials found that a single dose was 79% effective in reducing hospitalisation and death in high-risk adults with symptoms – but it is unclear how it will fare against the new Omicron variant.
Sotrovimab is thought to be most effective when taken during the early stages of infection – leading the MHRA to recommends its use as soon as possible and within five days of patients showing symptoms.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, added: ‘The Commission on Human Medicines and its Covid-19 Therapeutics Expert Working Group has independently reviewed the data and agrees with the MHRA’s regulatory approval.
‘Based on the data reviewed by the Commission and its expert group, it is clear sotrovimab is another safe and effective treatment to help us in our fight against Covid-19.’
It is the second monoclonal antibody to be authorised by the MHRA after molnupiravir.
But unlike molnupiravir, sotrovimab is administered by intravenous infusion (often a drip) over 30 minutes.
It is approved for individuals aged 12 and above who weigh more than 40kg.
The MHRA said it was too early to know whether the Omicron variant has any impact on sotrovimab’s effectiveness but that it will work with GSK to find out.
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