AstraZeneca’s Evusheld scores FDA approval for pre-exposure prevention of COVID-19

UNITED KINGDOM – The Food and Drug Administration (FDA) has approved Evusheld for the pre-exposure prophylaxis of COVID-19 in certain individuals 12 years of age and older weighing at least 40kg.

Evusheld is a combination of two long-acting antibodies, tixagevimab and cilgavimab, derived from B-cells donated by SARS-CoV-2 infected patients.

It was discovered at Vanderbilt University Medical Center in Nashville, Tennessee, with funding from the US Departments of Health and Human Services and Defense, and will be licensed to AstraZeneca in June 2020.

According to data submitted to the FDA, AstraZeneca’s Evusheld can reduce the risk of developing symptomatic COVID-19 by 77% when compared to placebo in unvaccinated adults without prior SARS-CoV-2 infection who are at high risk of inadequate immunization response.

The FDA’s EUA only authorizes the drug for adults and children aged 12 and up, weighing at least 40 kg, who are not currently infected with SARS-CoV-2 and have not recently been exposed to COVID-19.

Individuals must also have either a moderate to severely compromised immune system due to a medical condition or immunosuppressive medications or treatments, resulting in a potentially inadequate immune response to COVID-19 vaccination, or a history of severe adverse reactions to a COVID-19 vaccine and/or vaccine component.

Evusheld is not approved for the treatment of COVID-19 or the prevention of COVID-19 after exposure. The FDA also emphasized that Evusheld is not a replacement for vaccination among those for whom vaccination is advised.

Evusheld is a drug that combines two long-acting monoclonal antibodies that bind to different sites on the SARS-CoV-2 spike protein. The product is only approved for people who are not currently infected with SARS-CoV-2 and have not had a known recent exposure to someone who is infected with SARS-CoV-2.

The FDA approved Evusheld based on data from the phase 3 PROVENT trial, which included 5,197 participants from 87 sites in the United States, United Kingdom, Spain, France, and Belgium.

Participants were unvaccinated adults without a history of SARS-CoV-2 infection who had a higher risk of inadequate response to active immunization or a higher risk of COVID-19 infection, including those whose location or circumstances increased their chances of infection.

According to AstraZeneca, more than 75% of those enrolled had baseline comorbidities and other characteristics associated with an increased risk of severe COVID-19, such as immunosuppressive disease or receiving immunosuppressive medications, diabetes, severe obesity or cardiac disease, chronic obstructive pulmonary disease (COPD), chronic kidney (CKD), and chronic liver disease (CLD).

In terms of safety, Evusheld was well tolerated, with preliminary analyses revealing a balance of adverse events in the placebo and treatment groups.

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