UK approves Regeneron’s Covid antibody drug: Watchdog finds therapy which was used on Donald Trump slashes risk of hospitalisation by 70% and can PREVENT infection
- Britain’s medical regulator has approved the Covid antibody treatment in the UK
- Health Secretary Sajid Javid heralded the move as ‘fantastic news’
- Drug uses antibodies which bind to the virus to stop it from invading cells
A Covid antibody cocktail drug used to treat former US President Donald Trump has been approved for UK patients.
Britain’s medical regulator gave Ronapreve the green light after finding it could prevent infection and treat patients who were already sick.
Trials showed among patients with at least one risk factor for severe Covid given the drug it slashed their risk of death or hospitalisation by 70 per cent. A separate study found it dramatically reduced the risk of catching Covid.
Health officials will now decide who should get the drug. However, at a cost of £2,000 per patient, it is unlikely to be rolled out widely as a preventative.
Experts today called for it to be targeted at the most vulnerable Britons.
The treatment — made by Regeneron — is the first developed specifically to target Covid, after steroids and antiflammatories were repurposed to treat the virus.
Boris Johnson said the drug will be an ‘important weapon in fighting Covid, particularly for those who are immunocompromised’. Health Secretary Sajid Javid said it would be rolled out on the NHS ‘as soon as possible’.
The treatment is not a substitute for vaccination because the protection against Covid it sparks only lasts for up to four weeks, far less time than that from jabs.
The drug — which uses two different man-made antibodies to fight the virus — is administered by injection or intravenously.
Antibodies are molecules which bind to the SARS-CoV-2 virus spike proteins — which it uses to invade cells — to prevent an infection or clear the virus from the body.
The drug is a combination of two cloned antibodies, casirivimab and imdevimab (pictured), and could cost as much as £1,000 to £2,000 per patient
Donald Trump (pictured on Fox News) received Regeneron when he was ill with Covid. It was approved for use in the US in November last year
The treatment contains casirivimab and imdevimab which are injected together.
They are made by extracting Covid-fighting antibodies from patients who have recovered from the virus, and then multiplying them in a laboratory.
The Medicines and Healthcare products Regulatory Agency (MHRA) says it should be given ‘as soon as possible’ after a positive Covid test in at risk patients. Experts said it was most effective when given three days after a positive test.
Monoclonal antibody therapy is a type of treatment that is based on injecting antibodies into people who don’t have them.
Antibodies are proteins made by the body’s immune system that can attack a virus by sticking to it and preventing it from infecting healthy cells.
They are super-specific and are developed for specific viruses as and when they are needed – flu antibodies will not protect against Covid, for example.
People can either develop antibodies by catching the infection for real, when their body makes them naturally, or by getting a vaccine, which forces the body to make them using a blueprint.
For people who don’t have them and don’t have a healthy immune system that can make them quickly if they become infected, the antibodies can be injected.
Monoclonal antibodies are ones that are cloned in a lab, usually from a sample taken from a person who has recovered from coronavirus already.
Scientists can single out the strongest looking antibodies from the blood samples and then clone these to make a super high concentration of them in a fluid that is then injected into the patient’s body through a drip.
These antibodies should then recognise the virus and burst into action, attacking the virus as if they had been made by the person’s own immune system and buying time for the patient’s body to make its own.
Clinical trials testing them on people with Covid have produced mixed results, with some clearly reducing the risk of hospitalisation or death, and others showing little or no benefits.
In cases where doctors are aiming to prevent infection the drug should be administered every four weeks.
Clinical trials showed it slashed the time for Covid symptoms to subside in infected patients by four days, and cut the risk of hospitalisation and death by 70 per cent.
They also revealed it could prevent infection with the virus.
Of 753 people who tested negative for Covid-fighting antibodies and lived in the same house as a Covid-infected person who were given the drug, only 11 then caught the virus (1.4 per cent).
But when the drug was not administered as many as 59 people caught the virus (7.9 per cent).
Participants were tested for Covid before the drug was administered, to ensure they had not already caught the disease from the Covid-infected individual in their home. They had no underlying health conditions that put them at risk from the virus, and most were less than 65 years old.
The drug can be stored in a fridge. It was developed by US-based company Regeneron and Roche.
Professor Martin Landray, who co-led trials investigating Covid treatments including Ronapreve, said the licensing was an ‘important step forward’ but that the drug should be prioritised for the most at risk patients.
‘Covid is not a rare disease and many people get better of their own accord after a few days of nasty flu-like illness,’ Professor Landray said.
‘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.’
Professor Penny Ward, a medicine expert at Kings College London, said: ‘I think it is most likely to be used to prevent hospitalisations among people becoming sick with Covid who are at higher risk of needing hospital care or dying from the disease.
‘It might also be used to prevent Covid infections in people who are in contact with a confirmed Covid case and who might have reduced response to vaccination (for example people being treated for cancer or post-transplant).
‘It can also be used to curtail outbreaks in institutions (care homes, hospitals, prisons, critical workplaces).’
Mr Johnson said on Twitter: ‘Good news that MHRA has approved the first therapeutic treatment designed specifically for Covid.
‘Alongside our life-saving vaccine programme, this will be an important weapon in fighting Covid, particularly for those who are immunocompromised.’
Mr Javid said: ‘The UK is considered a world leader in identifying and rolling out life-saving treatments for Covid-19, once they have been proven safe and effective in our government-backed clinical trials.
‘This is fantastic news from the independent medicines regulator and means the UK has approved its first therapeutic designed specifically for Covid-19.
‘This treatment will be a significant addition to our armoury to tackle Covid-19 – in addition to our world-renowned vaccination programme and life-saving therapeutics 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.’
MHRA interim chief quality and access officer Dr Samantha Atkinson said: ‘We are pleased to announce the approval of another therapeutic treatment that can be used to help save lives and protect against Covid-19.
‘Ronapreve is the first of its kind for the treatment of Covid-19 and, after a meticulous assessment of the data by our expert scientists and clinicians, we are satisfied that this treatment is safe and effective.
‘With no compromises on quality, safety and efficacy, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data.’
The regulator said the Government and NHS will confirm how the treatment will be deployed to patients in due course.
Regeneron’s monoclonal antibody therapy hit headlines last year when it was given to Donald Trump and he branded it a ‘cure’ after being discharged from hospital.
The former American President was admitted to hospital in October after testing positive for the virus and suffering mild symptoms — including a fever and congestion.
Clinicians initially gave him remdesivir, an antiviral drug that slows down an infection giving the body more time to fight off the disease.
But Trump was then also administered with Ronapreve to help fight off the virus, which at the time was reserved for severely ill patients.
He spent three nights in hospital before being discharged. It is not clear where he caught the virus, but at the time Trump was campaigning for re-election.
Trump said in a video on Twitter at the time: ‘They gave me Regeneron… and other things, too, but I think this was the key. They gave me Regeneron. And it was, like, unbelievable – I felt good,’ Al Jazeera reported.
‘They call them therapeutics,’ he added. ‘To me it wasn’t therapeutic, it just made me better – I call that a cure.’
‘I think this was a blessing from God that I caught it. This was a blessing in disguise. I caught it. I heard about this drug. I said, ‘Let me take it.’ It was my suggestion. I said, ‘Let me take it.”
He vowed to make it available in the US, telling people ‘I want to get for you what I got, and I’m going to make it free.’
The US Food and Drug Administration approved the drug for emergency use on Covid patients on November 21.
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