Evusheld is made of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to attach to the spike protein of the SARS-CoV-2 virus at two different sites. When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection.
“Increasing COVID-19 cases, driven by the highly-transmissible BA.2 subvariant, and withdrawal of several pandemic public health measures make it important to protect vulnerable populations, such as the immunocompromised, from SARS-CoV-2 infection. The authorization of Evusheld for a broad population will allow health authorities in the EU to identify the populations who are most at-risk and need additional protection,” commented Christoph Spinner, consulting physician infectious diseases and pandemic officer at the University Hospital Rechts der Isar and adjunct teaching professor at the Technical University of Munich, in a release on the approval.
When asked how cost-competitive the drug would be, a spokesperson for AstraZeneca told us prices are confidential but that the company is "committed to working with international and government agencies around the world to make Evusheld accessible so that countries can potentially add it to their arsenal to tackle COVID-19."
Evusheld, continued the spokesperson, is an important addition to the fight against COVID-19, as a prevention for vulnerable populations at high risk of COVID-19 infection and as a treatment option for those with COVID-19, with potential to reduce the burden and costs on healthcare systems.
The EMA's CHMP, during its March meeting, also endorsed an increase in manufacturing capacity for the Pfizer/BioNTech COVID-19 vaccine: Comirnaty.
The recommended dose of Evusheld in Europe is 150mg of tixagevimab and 150mg of cilgavimab, administered as two separate sequential intramuscular injections.
The approval by the EU Commission was based on results from the Evusheld clinical development program, including data from the PROVENT Phase III pre-exposure prophylaxis trial.
That study showed a 77% reduction in the risk of developing symptomatic COVID-19 compared to placebo at the primary analysis and an 83% reduction at a six-month median analysis, with protection from the virus lasting at least six months, said the pharma giant. Evusheld was generally well-tolerated in the trial, it added.
AZ: Data indicates drug neutralizes Omicron variants
In its positive opinion on the drug, issued last week, EMA's human medicines committee (CHMP), noted that the study data were collected before the emergence of the high contagious Omicron subvariant, BA.2. “EMA will assess data in the coming weeks to evaluate whether an alternative dosing regimen could be appropriate for the prevention of COVID-19 resulting from emerging variants.”
AstraZeneca, meanwhile, said there here is a growing body of evidence from multiple independent in vitro and in vivo studies supporting the potential of Evusheld to protect against all Omicron variants globally.
“New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralizing activity against the emerging and highly transmissible BA.2 subvariant, which is the dominant strain in many European countries and currently accounts for over 60% of COVID-19 infections in Europe. This study also showed Evusheld reduced viral burden and limited inflammation in the lungs across all omicron variants," reported the company.
The drug is authorized for emergency use for pre-exposure prophylaxis of COVID-19 in the US and was recently granted conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for pre-exposure prophylaxis of COVID-19.
