Evusheld, created by Vanderbilt University Medical Center and licensed to AstraZeneca, is a long-acting antibody combination used in the prevention of Covid-19, and has been granted market authorization in the EU.
The European Commission granted the approval on the basis of the results from the Evusheld clinical development programme, which depicted strong results against Omicron.
In Europe, Omicron BA.2 subvariant of Covid-19 is the predominant strain, with 60% of cases caused by the Omicron virus.
Evusheld holds neutralising activity against the Omicron strain. In the PROVENT Phase III trial, Evusheld showed optimistic results with substantially reducing the risk of developing symptomatic Covid-19 by 77% and additionally provided protection against Covid-19 for at least 6 months. Overall, Evusheld was well-received in the study.
Evusheld is the only long-acting antibody combination that has shown to be effective in the prevention and treatment of COVID-19 in Phase III trials.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said, “The EU approval represents an important milestone in our efforts to help prevent COVID-19, and we will continue to work with governments across Europe to make Evusheld available as quickly as possible.”
“Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure.”
AstraZeneca is filing to obtain emergency use authorisation or marketing approval for Evusheld in both COVID-19 prophylaxis and treatment globally.
In Europe, the recommended dose of Evusheld is 150mg of tixagevimab and 150mg of cilgavimab, administered as two separate sequential intramuscular injections.
Evusheld can be used in adults or children above the age of 12 with a minimum weight of 40kg.
Around 3m people in the EU are immunocompromised by cancer and transplants. Evusheld may help prevent exposure to Omicron due to lack of protection from the Covid-19 vaccine for any patients.
Christoph D. Spinner, MD, said, “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 authorisation 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.”
AstraZeneca shares rose 0.6% to 9,900p on Monday morning following the news of Evusheld receiving market authorization in the EU.