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Evusheld approved by MHRA for COVID-19 prevention

Tixagevimab/cilgavimab (Evusheld), a combination of monoclonal antibodies, has been approved by the UK’s MHRA for prevention of COVID-19

Tixagevimab/cilgavimab (Evusheld) is a combination of two monoclonal antibodies that has been approved by the UK’s MHRA for use before exposure to COVID-19 in order to prevent the disease. The drug is therefore suitable for use in adult patients who have been deemed unlikely to mount an immune response from COVID-19 vaccination or in those where vaccination is not recommended.

The monoclonal antibody combination was issued an emergency use authorisation (EUA) by the FDA in the US in December 2021 for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and paediatric individuals (12 years of age and older weighing at least 40 kilograms. Evusheld is unsuitable for those currently infected with COVID-19 or who have had a recent and known exposure to a person infected with the virus. The two drugs are available as separate intramuscular injections and have been found to recognise non-overlapping sites, bound simultaneously to the S protein and neutralised wild-type COVID-19 virus in a synergistic manner. As a result, the manufacturer, AstraZeneca, has examined the value of Evusheld in three separate clinical studies although, to date, none of these have been published.

Evusheld clinical efficacy

Evusheld was examined in the PROVENT trial which was designed to assess the safety and efficacy of a single dose compared to placebo for the prevention of COVID-19. The trial included 5,197 participants and who were randomised 2:1 to a single 300 mg dose of Evusheld (AZD7442 in all press releases) or placebo and which was administered in two separate, sequential IM injections. The trial recruited individuals 18 years of age and over (including 43% who were older than 60 years of age) who would benefit from prevention, defined as having an increased risk for an inadequate response to active immunisation or having an increased risk for COVID-19 infection. Participants at the time of screening were unvaccinated and had a negative COVID-19 test. The primary efficacy endpoint of the trial was the first case of any COVID-19 PCR confirmed, symptomatic illness occurring after the dose before day 183. According to a press release from the manufacturer, Evusheld reduced the risk of developing symptomatic COVID-19 by 77% (95% CI 46 – 90%) in comparison to those given a placebo.

A second trial, STORM CHASER, was designed to explore post-exposure prophylaxis of COVID-19 in Adult patients. The trial included 1,121 participants, randomised 2:1 as before to either Evusheld or placebo, all of whom tested negative for COVID-19 prior to receiving treatment. Again, in a press release from the manufacturer, Evusheld reduced the risk of developing symptomatic COVID-19 by 73% (95% CI 27 – 90%) compared with placebo among those who were PCR negative at the time of dosing.

The third trial, TACKLE, explored the value of Evusheld given to adults who were non-hospitalised with mild-to-moderate COVID-19 and symptomatic for seven days or less, but this time, given a 600 mg dose of the drug. The primary efficacy endpoint of the trial was the composite of either severe COVID-19 or death from any cause through day 29. According to the manufacturer press release on TACKLE, Evusheld given to participants within five days of symptom onset saw a 67% reduced risk of developing severe COVID-19 or death compared with placebo.

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