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Health Secretary Sajid Javid described the drug molnupiravir as a fierce weapon in our pandemic “armoury”. He added: “This will be a game-changer for the most vulnerable patients.”
Crucially, the tablet can be taken at home without the need for a hospital visit and is the first to ward off the virus’s deadly effects.
Created by US drug companies Merck, Sharp and Dohme, the twice-a-day antiviral tablet can counteract the early onset of coronavirus.
Britain has bought 480,000 treatments, worth about £250million, after UK medicines regulator the MHRA yesterday approved the drug’s use.
The first doses will be dished out by the end of this month.
They will firstly be used on vulnerable patients such as care home residents who have tested positive and started showing symptoms.
Mr Javid yesterday gave the pill his backing.
He said: “Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for Covid-19.
“This will be a game-changer for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground- breaking treatment.
“The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments. We are working at pace across the Government, with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.
“This antiviral will be an excellent addition to our armoury against Covid-19.”
But Mr Javid stressed that vaccines are still our best way to see off the threat of Covid.
He added: “It remains vital everyone comes forward for their life-saving vaccine, particularly those eligible for a booster, to ensure as many people as possible are protected over the coming months.”
Earlier, clinical trials on 775 patients with early Covid found only 7.3 percent on molnupiravir were hospitalised ‑ compared to 14.1 percent given a placebo or dummy pill.
There were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of Covid.
The data suggested the new pill needs to be taken soon after symptoms develop to have an effect.
Molnupiravir, which will be sold under the brand name Lagevrio, targets an enzyme Covid uses to make copies of itself, introducing errors into its genetic code.
Trials show this helps prevent it from multiplying, keeping virus levels low in the body and reducing the severity of the disease.
Drug firm Merck said that approach should make the treatment equally effective against new variants of the virus as it evolves in the future.
The MHRA authorised it for use in those with mild to moderate Covid and at least one risk factor ‑ such as obesity, old age, diabetes or heart disease.
MHRA chief executive June Raine said: “Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that molnupiravir is safe and effective for those at risk of developing severe Covid and have granted its approval.
“It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously.
“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”
Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said: “In clinical trials, Lagevrio was found to be effective in reducing the risk of hospitalisation or death for at-risk adults with mild to moderate Covid by 50 percent.”
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The UK’s full order of 480,000 courses of the drug will hopefully all be delivered by the end of the year. It is hoped molnupiravir will provide an extra layer of defence heading into the winter.
Vaccines, which are being made slightly weaker by new variants of the virus, work by targeting the spike protein and were designed to tackle the original virus.
Because a lot of evolution happens on the spike protein, the immune systems of vaccinated people sometimes find it more difficult to recognise new variants.
Merck is the first company to report trial results of a pill to treat Covid, but other health firms are now working on similar treatments.
Comment by Dr June Raine
Yesterday, we achieved another first in the fight against Covid. After months of careful analysis and review, my agency ‑ the UK’s medicines regulator ‑ concluded that the antiviral molnupiravir cuts the risk of hospitalisation and death in people vulnerable to Covid.
Not only is it yet another treatment to add to our armoury, we are also the first country to approve it.
We have thoroughly reviewed its safety, quality and effectiveness, thanks to expert scientists and clinicians at the MHRA and the Government’s independent scientific advisers at the Commission on Human Medicines.
We are also the first to approve an antiviral against Covid that can be taken by mouth rather than being administered by injection.
This is important because we know such drugs are most effective when given at an early stage of infection. And the fact it comes as a capsule means it can be given outside a hospital setting, before the disease has progressed to a serious stage.
Let’s be very clear here, our safe and effective vaccines remain the best line of defence and have saved over a hundred thousand lives so far in the UK alone. But not everyone responds in the same way.
We know, for example, that individuals with weak immune systems are more likely to mount a poor response following vaccination.
We also know having obesity, heart disease, diabetes or being older leaves you at greater risk. For such people, molnupiravir could be lifesaving.
Of course, our work doesn’t stop here. Our team of safety experts work hard behind the scenes to make sure this new treatment continues to be monitored. The safety of the UK public is always our top priority.
Molnupiravir is another step on the way to beating this disease, bolstering our fantastic vaccination programme.
Dr June Raine is chief executive of the Medicines and Healthcare products Regulatory Agency (MRHA)
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