UK approves Covid antibody drug as medical watchdog finds it can PREVENT infection
A Covid antibody cocktail drug used to treat former US President Donald Trump has finally 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 that among patients with at least one risk factor for severe Covid, it slashed their risk of death or hospitalisation by 70 per cent.
A separate study found it dramatically reduced the risk of catching Covid, but protection only lasts for a month. 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 approved treatment is the first developed specifically to target Covid, after steroids and anti-inflammatories were repurposed to treat the virus.
It has been available in the US since November.
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. It is made by US biotech firm Regeneron and Swiss company Roche.
Separately, a study of an antibody drug made by AstraZeneca found it reduced the risk of developing symptomatic disease by 77 per cent in the immunosuppressed.
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
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.
It comes as AstraZeneca revealed today that its Covid antibody treatment — which is being developed for people who cannot be vaccinated — reduced the risk of developing virus symptoms by 77 per cent.
And the drugs company said the treatment could give people up to 12 months of protection from Covid.
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.
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 is being distributed by Regeneron in the US, where it is called REGEN-COV, and by Roche outside the US, under the name Ronapreve.
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).’
Professor Ward added: ‘The product has been shown to both reduce the need for hospitalisation and death when started early (within 3 days of a positive PCR test) among subjects infected with SARS-CoV-2.’
In a tweet this morning, Prime Minister Boris Johnson said: ‘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.
It comes as an antibody treatment called AZD7442, which is being developed by AstraZeneca, has displayed promising results in trials.
In a study of more than 5,000 adults, the cocktail of two long-lasting antibodies was injected into the muscles in the hopes of protecting against Covid.
No one who received the treatment experienced severe Covid or died from the virus, compared to the control group where there were three severe cases and two deaths.
And those who received the antibody injection were 77 per cent less likely to show Covid symptoms if they were infected.
It is the first non-vaccine antibody treatment modified to provide potentially long-lasting protection that has demonstrated prevention of Covid in a clinical trial, the drugs company said.
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.
