The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a grant of marketing authorisation to AstraZeneca’s antibody combination Evusheld (AZD7442), for Covid-19 prevention in the European Union (EU).
Evusheld is a cocktail of two long-acting antibodies (LAAB), tixagevimab (AZD8895) and cilgavimab (AZD1061), obtained from B-cells of convalescent patients following Covid-19.
In June 2020, the Vanderbilt University Medical Center-discovered antibodies were licenced by AstraZeneca.
As per the recommendation, the LAAB combination is intended for Covid-19 pre-exposure prophylaxis in adults, as well as adolescents aged 12 years and above.
Intramuscular doses of 150mg tixagevimab and 150mg cilgavimab, given sequentially, have been recommended for use in Europe.
The CHMP’s positive opinion is based on the assessment of Evusheld data, which comprises findings from the Phase III PROVENT pre-exposure prophylaxis clinical trial.
According to results from the trial, Evusheld provided a 77% decline in symptomatic Covid-19 development risk versus the placebo at the initial analysis, and an 83% decline at a six-month median assessment.
The antibody cocktail offered protection from the SARS-CoV-2 virus that lasted for a minimum of six months, and was found to be generally well-tolerated.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing Covid-19.
“Evusheld has the potential to provide long-lasting protection to vulnerable populations, such as the immunocompromised, who can’t mount an adequate response to a Covid-19 vaccine, and we’ll continue to work with governments in Europe to make Evusheld available as quickly as possible.”
In December last year, the US Food and Drug Administration granted emergency use authorisation to Evusheld for Covid-19 prevention.
The LAAB combination is also authorised for emergency use in six European countries.