MHRA Go-Ahead Given To New COVID-19 Preventative Medicine –safeMedicate

by Liz Seyi Digital marketing manager

As the worldwide battle continues against the latest strains of COVID-19, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of a new medicine, Evusheld (tixagevimab/cilgavimab), for the purposes of preventing the disease. 

The agency said that authorisation of the treatment’s use was endorsed by the Commission on Human Medicines (CHM) – the Government’s independent expert scientific advisory body – following a careful review of the evidence.  

How does Evusheld work against the coronavirus? 

The MHRA described the AstraZeneca-developed medicine as effectively bringing together two long-acting antibodies. According to the agency, the treatment binds to the spike protein on the outside of the SARS-CoV-2 virus, thereby stopping the virus’s entrance into human cells. 

Approval was given to the medicine based on it being used before the patient is exposed to the risk of becoming infected with the virus. 

While the MHRA stated that vaccination remained the most effective guard against infection “for most people”, the agency explained that Evusheld had been authorised for use in adults for whom vaccination is not recommended, or who only have a low chance of mounting an immune response from vaccination for COVID-19. 

It is understood that to receive the medicine, a patient should not presently be infected with the COVID-19 virus; nor should they have had recent known exposure to an individual infected with the virus. 

The agency said that a healthcare professional should give a single dose of the two medicines – Tixagevimab and Cilgavimab – in the form of two injections into a muscle. 

The results of a clinical trial in adults indicated that Evusheld was associated with a 77% lower risk of developing symptomatic COVID-19, and that a single dose was sufficient to give the patient protection from the virus for a minimum of six months. 

The MHRA said that there wasn’t yet sufficient data to ascertain Evusheld’s effectiveness against Omicron, or the period for which it might be effective against this variant. However, the agency indicated that it would seek to determine this by working with AstraZeneca. 

“Satisfied it meets the expected standards” 

Chief executive at the MHRA, Dr June Raine, commented: “After a careful review of the data, I am pleased to confirm that we have authorised another medicine to help protect against the effects of COVID-19. 

Evusheld is a “pre-exposure prophylaxis” treatment, meaning it is taken to prevent COVID-19 before the risk of acquiring infection.” 

Meanwhile, Professor Sir MunirPirmohamed – Chair of the CHM – stated: “We have carefully reviewed data on the medicine’s safety, quality and effectiveness, and are satisfied it meets the expected standards.” 

As a healthcare professional led team we have been pleased to offer our safeMedicate Managing Covid-19 module free of cost to NHS colleagues throughout the COVID-19 pandemic.

Our COVID-19 Education Support module is our contribution to supporting healthcare practitioners competence updating in COVID-19 related drug dosage calculations.

In addition to our COVID-19 module, you may also be interested in our international suite of safeMedicate authentic learning and assessment environments. Please feel free to contact us for further information or visit oursafeMedicate Interactive Demonstration (SiD) to experience our range of learning and assessment modules for yourself.

 

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Created on May 5th 2022 02:23. Viewed 137 times.

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