Covid patients in UK to be treated with man-made antibodies after new drug approved
New treatment to be rolled out via the NHS ‘as soon as possible’, says health secretary
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Your support makes all the difference.Covid patients in the UK are to be treated with man-made antibodies that prevent and fight coronavirus infection after approval was granted by the medicines regulator.
Health secretary Sajid Javid said the treatment, which was used on former US president Donald Trump after he fell ill with Covid-19, would be rolled out through the NHS “as soon as possible”.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the clinical trial data they had assessed has shown Ronapreve may be used to prevent infection, treat symptoms of acute Covid-19 infection and can reduce the likelihood of being admitted to hospital due to the virus.
The drug, administered by injection or infusion, acts at the lining of the respiratory system and combines two antibodies that bind to different places on the coronavirus spike protein, the part of the virus responsible for gaining entry to human cells. This neutralising process blocks infection and helps to accelerate the clearance of the virus.
It’s hoped that the dual antibody approach will maintain the effectiveness of the treatment if a new coronavirus variant emerges with notable mutations to its spike protein.
Scientists believe the treatment will be most likely used to prevent hospitalisation among people becoming sick with Covid who are at higher risk of hospitalisation and death from the virus.
This could include immunocompromised individuals, such as those with an autoimmune disorder or receiving cancer treatment, who might not have responded as well to vaccination.
The drug is the first monoclonal antibody combination product approved for use against Covid-19 in the UK.
Monoclonal antibodies are laboratory-made proteins that act like natural human antibodies in the immune system.
The health secretary said the treatment was a “significant addition to our armoury to tackle Covid-19”, alongside the UK’s vaccines and life-saving therapeutics such as dexamethasone and tocilizumab.
“We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible,” he added.
UK trials for the drug, developed by pharmaceutical firms Regeneron and Roche, took place before widespread vaccination and the emergence of virus variants.
Martin Landray, a professor of medicine and epidemiology at the University of Oxford, said there have been a number of studies into the treatment in an out-of-hospital setting, “each with positive results – reducing viral clearance and reducing the risk of hospitalisation”. He added: “There have been no major safety concerns.”
Dr Samantha Atkinson, interim chief quality and access officer at the MHRA, said the regulator had conducted a “meticulous assessment” of the clinical trial data and was “satisfied that this treatment is safe and effective”.
The US has approved a number of monoclonal antibody products throughout the pandemic, including a Regeneron-made treatment that was used on President Trump last autumn.
But patients in America have struggled to access the drug, which is expensive, and Prof Landray said the NHS would also be restricted by costs when determining which people will be offered the treatment.
“The challenge going forward will be in determining which patients should be prioritised for this treatment,” he said. “Covid is not a rare disease and many people get better of their own accord after a few days of a nasty flu-like illness.
“It would be hard to justify giving what are likely to be limited supplies of a relatively expensive treatment to huge numbers of people who are likely to get better on their own.
“On the other hand, it may play an important role in patients who are at higher risk of developing severe infection and who are more likely to end up in hospital.”
The MHRA said the government and NHS will confirm how the treatment will be deployed to patients in due course.
Penny Ward, a visiting professor in pharmaceutical medicine at Kings College London, said the drug could reduce hospitalisation risk by “about 70 per cent” – depending on how much the treatment is used throughout the NHS.
“With this additional tool at our disposal we stand a greater chance of being able to prevent the toll of Covid on hospital services and save more lives,” she said. “It’s a good news day.”
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