First monoclonal antibody drug approved to treat Covid, as separate trial shows promise for vulnerable patients

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (20 August) approved the first monoclonal antibody therapy for the treatment and prevention of Covid-19 in the UK.  

Ronapreve, developed by Regeneron and Roche, is the first treatment of its kind designed specifically to combat Covid. It combines two monoclonal antibodies in a drug that’s administered by injection or infusion. 

It works by binding to the virus and stopping it from entering the respiratory system, thereby acting to ‘prevent infection, promote resolution of symptoms of acute Covid-19 infection and… reduce the likelihood of being admitted to hospital due to Covid-19’, the regulator said. 

The drug underwent clinical trials before mass vaccination was rolled out, and the MHRA started reviewing data on a rolling basis in January.  

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Health secretary Sajid Javid said: ‘This treatment will be a significant addition to our armoury to tackle Covid-19 – in addition to our world-renowned vaccination programme and life-saving therapeutics dexamethasone and tocilizumab.  

‘We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.’ 

Details on how that will happen will be issued by the NHS and government ‘in due course’ the MHRA added.  

This comes as AstraZeneca today (20 August) published results from its PROVENT pre-exposure prophylaxis trial, showing that a combination of two long-acting antibodies reduced the risk of developing Covid-19 symptoms by 77%, compared with a placebo. 

The therapy, known as AZD7442, is ‘the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of Covid-19 in a clinical trial’, the pharma giant said. 

Its analysis was based on 5,172 study participants who were not infected with Covid at the start of the trial. More than three-quarters of participants had co-morbidities that trigger a lower immune response to the Covid vaccine. 

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The drug is administered by intramuscular injection and the trial data show promise for providing extra protection for clinically extremely vulnerable people. 

Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, said: ‘We need additional approaches for individuals who are not adequately protected by Covid-19 vaccines.  

‘We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines.’ 

More data from the trial will be released later this year, AZ said. 

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Vulnerable people could begin receiving a Covid booster vaccine from next month, with pharmacies in England set to lead the roll-out.  

Scottish and Welsh pharmacies, however, are currently not included in plans to administer booster jabs in the devolved nations.