A potentially “life-saving” treatment called Paxlovid has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use among adults who could be vulnerable to coronavirus due to age, weight or a prior chronic illness.
The decision comes after the regulator found the drug – which can be taken at home – was safe and effective at reducing the risks of being admitted to hospital and death in people with mild to moderate coronavirus infection and who are also at an increased risk of developing severe disease.
In a clinical trial in high-risk adults with symptomatic coronavirus infection, it was found to reduce the risk of being admitted to hospital and of death by almost 90%.
Health Secretary Sajid Javid said: “The UK has been a world leader at finding and rolling out Covid-19 treatments to patients.
“This is further proved by the MHRA being one of the first in the world to approve this life-saving antiviral.
“We are also leading the whole of Europe in the number of antivirals we’ve bought per person – with over 2.75 million courses of this antiviral secured for NHS patients by the Antivirals Taskforce.
“The booster campaign, testing and antiviral defences ensure our country is in the strongest possible position to deal with the threat posed by Omicron as we head into the new year.”
Paxlovid is an antiviral medicine with a combination of active ingredients that works by inhibiting a protease required for virus replication.
This prevents it from multiplying, keeping virus levels low and helping the body to overcome the viral infection.
The two active substances of Paxlovid come as separate tablets that are packaged together and taken together, twice a day by mouth for five days.
Dr June Raine, MHRA chief executive, said: “Today we have given our regulatory approval for Paxlovid, a Covid-19 treatment found to cut related hospitalisations and deaths by 89% when taken within three days of the start of symptoms.
“We now have a further antiviral medicine for the treatment that can be taken by mouth rather than administered intravenously.
“This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage.
“I hope the announcement today gives reassurance to those particularly vulnerable to Covid-19, for whom this treatment has been approved. For these individuals, this treatment could be life-saving.”
Based on the clinical trial data, MHRA said it had found Paxlovid is most effective when taken during the early stages of infection and so recommends its use as soon as possible and within five days of the start of symptoms.
It has been authorised for use in people aged 18 and above who have mild to moderate Covid-19 infection.
Ben Osborn, country manager at Pfizer UK, said: “This milestone is an important moment in our continued fight against Covid-19, offering the NHS another possible treatment option as cases continue to rise.
“This at-home therapy, shown in clinical trials to reduce hospitalisations and save lives, has the potential to lessen the devastating impact of a virus that has now taken over five million lives globally.”