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Prophylactic Covid treatment with GP potential approved by MHRA

Prophylactic Covid treatment with GP potential approved by MHRA

A new prophylactic monoclonal antibody treatment for Covid – that could be administered by GPs – has been approved by the UK medicines regulator.

Evusheld, a combination of tixagevimab/cilgavimab developed by AstraZeneca, is given as two intramuscular injections before exposure to Covid-19 to people who have had a poor immune response to vaccination.

The Medicines and Healthcare products Regulatory Agency (MHRA) said in clinical trials the treatment was found to reduce the risk of developing symptomatic Covid-19 by 77%, with protection from the virus continuing for at least six months.

But work is ongoing to assess the effectiveness of Evusheld against Omicron, the MHRA added.

The drug works by providing long-acting antibodies which bind to the SARS-CoV-2 spike protein preventing it from entering cells.

MHRA chief executive Dr June Raine said: ‘While the Covid-19 vaccines continue to be the first-line defence against Covid-19, we know that some people may not respond adequately to these vaccines and for a small number of individuals Covid-19 vaccines may not be recommended for other reasons, such as a previous allergic reaction to one of the vaccine ingredients.

‘For these people, Evusheld could provide effective protection against Covid-19.’

Professor Penny Ward, visiting professor in pharmaceutical medicine at King’s College London, said: ‘Evusheld is a combination of two monoclonal antibodies – tixagevimab and cilgavimab – which is given as two intramuscular injections and thus can be given in a GP surgery/in the community rather than, as for other monoclonal antibodies, needing to be given by IV infusion.

‘This treatment could therefore be a good way to protect patients who are not able to respond normally to vaccination and allow this group to be able to return to a more normal life than they are currently able to enjoy.

‘Many of these folks are continuing to shield while Covid is still circulating in the community and this agent could help them feel more confident to return to a more normal life.’

She added: ‘Let us hope the NHS has ordered enough to offer this to all that can benefit.’

Professor Alex Richter, director of the clinical immunology service at University Hospitals Birmingham and member of British Society for Immunology Covid-19 Taskforce  said he was delighted the treatment had been approved.

‘We hope this translates quickly into clinical use within the NHS. The safety and effectiveness of Evusheld has been assessed through several clinical trials and it is already in use as an approved therapy in several other countries.  

‘There are many patients with immunodeficiency who have not responded to vaccination and so remain vulnerable to Covid; using monoclonal antibodies as a preventative treatment will give a lot of hope to these patients as the country opens up from Covid and infection rates are still so high.’

The Department of Health and Social Care told Pulse that its Therapeutics Taskforce is actively engaging with AstraZeneca and will study product details carefully ahead of further decisions on a rollout of the treatment.

A spokesperson said: ‘The UK has so far identified and secured multiple life-saving Covid-19 treatments for NHS patients which have helped thousands of people.

‘This is welcome news from our renowned medicines regulator and we will continue to closely monitor investigations into the treatment’s effectiveness against new variants.’


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