New COVID-19 variants prompt FDA to revoke Evusheld’s EUA

The FDA has withdrawn the emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab with cilgavimab) as a COVID-19 pre-exposure prophylaxis owing to the emergence of new variants.

Evusheld has been found to be ineffective against several omicron subvariants, including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB, and XBB.1.5.1.

The XBB.1.5 subvariant is becoming more prevalent in the U.S., accounting for approximately half of COVID-19 infections in the country.

In 2022, AstraZeneca announced that Evusheld reduced the risk of developing symptomatic COVID-19 by about three-quarters in a Phase 3 study.

In 2022, AstraZeneca revealed the results of a Phase 3 study, showing that Evusheld reduced the likelihood of experiencing symptomatic COVID-19 by roughly 75%. The results were summarized in NEJM in an article noting that the antibody cocktail retained some protection against an early omicron variant.

From Evush…
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EU approves AstraZeneca’s Evusheld COVID-19 antibody cocktail

AstraZeneca (LON:AZN) has announced that its long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has received marketing authorization in the European Union. 

Formerly known as AZD7442, Evusheld is indicated for treating individuals 12 and older infected with SARS-CoV-2 who are at risk for severe COVID-19. The indication is limited to those weighing at least 40 kg who do not need supplemental oxygen. 

European regulators based their recommendations on data from the placebo-controlled Phase 3 TACKLE COVID-19 study that demonstrated a single intramuscular (IM) dose of Evusheld. 

Evusheld thus differs from other COVID-19 antibodies that require an infusion. 

The placebo-controlled TACKLE study found that Evusheld provided clinically and statistically significant protection against severe COVID-19 or death from any cause compared. 

Outcomes were best for individuals who received Evusheld therapy at an early stage of disease pr…

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AstraZeneca’s Evusheld offered strong protection against COVID-19 in Phase 3 study

In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo. 

The drug is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19. 

Evusheld won a EUA in December 2021.

The adults enrolled in the trial had an inadequate response to COVID-19 vaccination, an elevated risk of exposure to SARS-CoV-2 or both. Subjects were either obese, immunocompromised, had pre-existing health conditions such as heart failure or chronic kidney disease, or were 60 years of age or older. 

After receiving a single 300 mg intramuscular dose of Evusheld, concentrations of the drug remained elevated for six months after administration, according to a pharmacokinetic analysis. 


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