Coronavirus patients in Britain can now be treated with remdesivir, the Ebola drug which has shown promise in battling the infection.
The Department of Health announced today that adults and teenagers with severe COVID-19 will be allowed to be treated with remdesivir if they fit specific criteria.
This makes the drug, which destroys a part of the virus in order to stop it reproducing, the closest thing doctors have to a cure or treatment for the disease.
The criteria for who will get it have not been laid out by the Government but doctors will be expected to decide on a case-by-case basis who is most likely to benefit.
Early trials of remdesivir have suggested that it can speed up people’s time to recovery by four days, British officials said.
Doctors in the US and Japan are already using the medication to treat COVID-19 patients under emergency access schemes, and the UK is now following suit in the face of incontrovertible scientific evidence.
It is expected to be available immediately to patients across England, Wales, Scotland and Northern Ireland.
Lord James Bethell, Government minister for innovation, said: ‘This shows fantastic progress.
‘As we navigate this unprecedented period, we must be on the front foot of the latest medical advancements, while always ensuring patient safety remains a top priority.
‘The latest, expert scientific advice is at the heart of every decision we make, and we will continue to monitor remdesivir’s success in clinical trials across the country to ensure the best results for UK patients.’
Remdesivir may be the closest thing doctors currently have to a cure for the coronavirus, after trials showed it can shave days off patients’ recovery times
Remdesivir, which is produced by the California-based company Gilead Sciences, has been approved under the Early Access to Medicines Scheme (EAMS).
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the go-ahead for NHS doctors to use it on people who are seriously ill with COVID-19.
Officials said: ‘Allocation of the drug will be based on expert clinical advice and will take into consideration the situation where it is most likely to provide the greatest benefit.’
The MHRA’s green light means the drug can be used before it has been officially licensed for prescription.
Usually, drugs have to go through lengthy testing and approval processes which take into account large amounts of scientific evidence and cost-effectiveness.
MHRA chief executive, Dr June Raine, said: ‘We are committed to ensuring that patients can have fast access to promising new treatments for COVID-19.
‘We will continue to work closely with the Department of Health and Social Care and other healthcare partners on protecting public health in the UK by prioritising our essential work on clinical trials, access to medicines, and the development of vaccines.’
Remdesivir is the first medication to get approval for use outside of a clinical trial in the UK.
It is an anti-viral drug that works by crippling an enzyme called RNA polymerase, which is vital for the virus to reproduce and spread. By damaging this, the drug may be able to stop the coronavirus in its tracks.
Other drugs which work in different ways are being used on NHS patients are part of clinical trials, but these are much less available.
Only limited numbers of people can be enrolled in trials and only certain people – usually otherwise healthy patients – are eligible for them.
For those who do make it onto trials there is often still a 50/50 chance that they get a placebo – a fake drug – anyway.
The two major clinical trials under way in Britain are named Recovery and REMAP-CAP.
On Recovery, which is being led by the University of Oxford but taking place across the country, patients may be given one of the following drugs:
- Lopinavir-Ritonavir (normally used to treat HIV)
- Dexamethasone (a steroid)
- Azithromycin (pneumonia; Lyme disease; chlamydia)
- Tocilizumab (rheumatoid arthritis)
- Hydroxychloroquine (malaria prevention; lupus; rheumatoid arthritis)
Doctors are also testing whether people benefit from a treatment called convalescent plasma, in which patients are given part of the blood of someone who has already recovered from the virus.
This, it is hoped, could introduce the antibodies – disease-fighting substances – needed to fend off the disease and bypass the body’s own process of developing them, which takes weeks after infection.
It is less clear which medicines are being used in the REMAP-CAP trial, which is described as an ‘adaptive’ trial meaning the treatments used change over time.
Britain’s good news comes alongside a blow to global hopes of finding a cure after the World Health Organization announced it was suspending a trial of chloroquine.
The anti-malarial drug, which has caused a storm since US President Donald Trump revealed he is taking it regularly to try and protect himself, was one of the first to show promise.
But it is known to cause heart problems in large doses, and appears to be ineffective against COVID-19 in small doses.
Director of the WHO Dr Tedros Adhanom Gebreyesus announced the suspension yesterday after a study published in The Lancet suggested COVID-19 patients might be more likely to die if given the drug.
Professor Trudie Lang, at the University of Oxford, said: ‘The WHO temporarily halting the use of chloroquine in COVID-19 clinical trials highlights why we need to run carefully designed clinical trials during outbreaks.
‘This enables us to learn as quickly as possible about whether potential therapies can tackle the virus and are safe. Properly designed and managed clinical trials are the only way we can see whether drugs might also cause harm. They are designed to assess the safety of the drug relative to the ability to bring any benefit.’