A new pill has been approved for adults in Britain who are at high risk of developing severe Covid-19.
Paxlovid, created by Pfizer Inc, is designed for over 18s with mild to moderate illness who are susceptible to contracting coronavirus.
The oral tablet has now been approved by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), which says it will help reduce the risk of hospitalisation and death in people with mild to moderate bouts of the infection.
A rigorous review of its safety, quality and effectiveness has been carried out.
Developed by Pfizer, Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that work 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. Ritonavir slows the breakdown of the second ingredient PF-07321332 in the body, thereby increasing its effectiveness.
The tablet must be taken twice a day for five days.
But PF-07321332 is a new antiviral, meaning that it has not been approved for use before. Ritonavir, though, has been used alongside some HIV medicines for many years to ‘boost’ their activity, which is similar to what it is doing for PF-07321332.
In a clinical trial in high-risk adults with symptomatic COVID-19 infection, a five day treatment course of Paxlovid reduced the risk of COVID-19 related hospitalisation and death within 28 days by 89% when compared to a placebo group when treatment was started within 3 days of the onset of COVID-19 symptoms.
The number of hospitalisations and deaths were 0.8% (3 out of 389) in the Paxlovid group compared with 7% (27 out of 385) in the placebo group. Similar favourable results were seen in patients when treatment was started within 5 days of the start of symptoms.
Based on the clinical trial data, Paxlovid is most effective when taken during the early stages of infection.
Dr June Raine, MHRA Chief Executive, said:“Today we have given our regulatory approval for Paxlovid, a COVID-19 treatment found to cut COVID-19 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 of COVID-19 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."
Health and Social Care 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.”
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