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 progression.
The TACKLE study focused on non-hospitalized adults with mild-to-moderate COVID-19 who had symptoms for seven days or less.
Some 90% of study volunteers had a high risk of developing severe COVID-19 as a result of co-morbidities or age.
AstraZeneca noted that the drug was generally well tolerated in the study.
Evusheld was also the focus of the Phase 3 PROVENT and STORM CHASER studies. The latter focused on a subset of individuals who received treatment within three days of exposure to SARS-CoV-2.
Vanderbilt University originally developed the pair of antibodies.
According to the university’s press outlet, Vanderbilt researchers developed the monoclonal antibodies in only 25 days.
Dr. James Crowe, director of the Vanderbilt Vaccine Center, led the development work, using blood from one of the first U.S. patients infected with COVID-19. Vanderbilt researchers identified two naturally occurring antibodies in COVID-19 survivors, which they later dubbed cilgavimab and tixagevimab.
“Despite the remarkable efficacy of COVID-19 vaccines in the overall population, patients with an impaired immune system remain at very high risk to develop severe COVID-19 requiring hospitalization,” said Dr. Michel Goldman, professor, Institute for Interdisciplinary Innovation in Healthcare at Université Libre de Bruxelles.
Goldman said, “Evusheld represents an important new treatment option to protect patients infected with the SARS-CoV-2 virus against severe disease and death.”
AstraZeneca notes that in vitro data suggest that Evusheld retains its potency against the omicron BA.5 sublineage, which is currently the most common subvariant in Europe and many other countries.
AZN shares were up 1.75% in mid-day trading to £10,307.67 in afternoon trading on the London Stock Exchange.
FDA has also authorized the antibodies for pre-exposure use.
AstraZeneca emerged as an early player in the COVID-19 vaccine race, but saw demand for its vaccine fall after European regulators found a possible link with the vaccine to very rare cases of blood clots with low blood platelets.