The UK has become the first country in the world to approve an oral antiviral pill, molnupiravir, to treat Covid.
It was given the go-ahead by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the government’s independent scientific advisory body, the Commission on Human Medicines, on Thursday.
The approval of the pill – also known as Lagevrio – has been hailed by health secretary Sajid Javid as a “historic day for our country”, declaring the medication a “gamechanger”.
The pill is said to cut the risk of hospitalisations or death from Covid by approximately half.
It is also the first Covid medication which can be taken as a pill rather than an injection or IV drip, meaning it can be administered outside of a hospital setting before the infection progresses and so could lessen the strain on the NHS.
The developers Merck said the treatment should be just as effective against potential future variants of Covid too.
It reduces the risk of hospitalisation and death in Covid patients among people with mild to moderate infections who are at risk of developing severe disease.
Four of the pills have to be taken twice a day for five days.
It stops the virus from replicating by introducing an error into its genetic code, meaning Covid levels in the body should remain low.
This prevents a relatively low-level infection worsening and so could reduce hospitalisation numbers.
MHRA explained: “Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive Covid-19 test and within five days of a symptoms onset.”
Regulators have decided the pill can be used for people who have mild to moderate Covid and at least one risk factor for developing severe illness such as obesity, diabetes, heart disease or being over 60.
The health secretary explained: “We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.”
Further details on its release have not been announced.
Although the pill was developed by US drug companies – and originally created to target the flu – regulators in the US and the EU are behind the UK in their evaluations.
The UK has already ordered 480,000 courses of the drug to be delivered by the end of the year, although Downing Street has not revealed how much this will cost.
It has also ordered 250,000 courses of a similar new drug developed by Pfizer which is yet to receive official approval.
Still, governments around the world – including Australia, Singapore and South Korea – have already ordered large batches of molnupiravir after positive results from stage 3 clinical trials were recently published.
The US has already made an advance purchase of 1.7 million courses, at approximately $700 or £513 for each course, while the food and drug administration advisory committee is set to evaluate safety and efficacy data of the pill at the end of the month, November 30.
David Dowdy, associate professor of epidemiology at Johns Hopkins University School of Medicine in Baltimore warned that it was not a perfect cure.
According to the Financial Times, he said: “Since the drug doesn’t stop infection I’m not sure I’d go so far as calling it a game-changer in the way the vaccines have been.”
It was given the go-ahead by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the government’s independent scientific advisory body, the Commission on Human Medicines, on Thursday.
Why is this a big deal?
The approval of the pill – also known as Lagevrio – has been hailed by health secretary Sajid Javid as a “historic day for our country”, declaring the medication a “gamechanger”.
The pill is said to cut the risk of hospitalisations or death from Covid by approximately half.
It is also the first Covid medication which can be taken as a pill rather than an injection or IV drip, meaning it can be administered outside of a hospital setting before the infection progresses and so could lessen the strain on the NHS.
The developers Merck said the treatment should be just as effective against potential future variants of Covid too.
So what does this pill actually do?
It reduces the risk of hospitalisation and death in Covid patients among people with mild to moderate infections who are at risk of developing severe disease.
How does it work?
Four of the pills have to be taken twice a day for five days.
It stops the virus from replicating by introducing an error into its genetic code, meaning Covid levels in the body should remain low.
This prevents a relatively low-level infection worsening and so could reduce hospitalisation numbers.
MHRA explained: “Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive Covid-19 test and within five days of a symptoms onset.”
Who will be able to take it?
Regulators have decided the pill can be used for people who have mild to moderate Covid and at least one risk factor for developing severe illness such as obesity, diabetes, heart disease or being over 60.
So, when will people get access to it?
The health secretary explained: “We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.”
Further details on its release have not been announced.
Why is the UK the first to approve it?
Although the pill was developed by US drug companies – and originally created to target the flu – regulators in the US and the EU are behind the UK in their evaluations.
The UK has already ordered 480,000 courses of the drug to be delivered by the end of the year, although Downing Street has not revealed how much this will cost.
It has also ordered 250,000 courses of a similar new drug developed by Pfizer which is yet to receive official approval.
Still, governments around the world – including Australia, Singapore and South Korea – have already ordered large batches of molnupiravir after positive results from stage 3 clinical trials were recently published.
The US has already made an advance purchase of 1.7 million courses, at approximately $700 or £513 for each course, while the food and drug administration advisory committee is set to evaluate safety and efficacy data of the pill at the end of the month, November 30.
But, there is a catch
David Dowdy, associate professor of epidemiology at Johns Hopkins University School of Medicine in Baltimore warned that it was not a perfect cure.
According to the Financial Times, he said: “Since the drug doesn’t stop infection I’m not sure I’d go so far as calling it a game-changer in the way the vaccines have been.”
