Evusheld COVID-19 therapy approved in EU
Posted: 21 September 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Evusheld becomes first and only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe.
AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442) antibody combination, has been approved by the European Commission (EC) for administration to COVID-19 patients in the European Union (EU).
The approval was based on Phase III trial data, where the combination drug was given to those affected with mild-to-moderate symptoms who had a high probability of developing severe COVID‑19. Those taking part in the trial were non-hospitalised adults who were symptomatic for seven days or less.
The TACKLE Phase III COVID-19 treatment trial was a randomised, double-blind, placebo-controlled, multi-centre trial. It focused on evaluating the safety and efficacy of a single 600mg intramuscular (IM) dose of Evusheld (300mg each of cilgavimab and tixagevimab) compared to placebo.
The trial was performed at 95 sites in the US, Latin America, Europe and Japan. A total of 903 participants were randomised 1:1 to receive either Evusheld (n = 452) or a saline placebo (n = 451).
The treatment dose of Evusheld in Europe is recommended at 300mg of tixagevimab and 300mg of cilgavimab, given separately. Both counterparts are to be administered as sequential IM injections.
The results showed that Evusheld offered patients considerable clinical and statistical protection against the virus progressing to a severe stage or to death (from another cause) compared to placebo. In the trial, 95 percent of participants were at high risk of severity progression, contributing factors were co-morbidities or age.
It was also observed that those treated with Evusheld sooner after contracting the virus, had improved outcomes.
“Many people, including those who are immunocompromised, older adults and those with underlying health conditions, are at high risk of severe disease, hospitalisation and death if they become infected. Evusheld, delivered in a convenient intramuscular formulation, is now a much-needed new COVID-19 treatment option for these vulnerable populations,” explained Professor Dr Michel Goldman, Institute for Interdisciplinary Innovation in Healthcare, Université Libre de Bruxelles, Belgium, and former Executive Director of the European Innovative Medicines Initiative.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, noted that: “With this approval, Evusheld is now the only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe, allowing us to protect even more people from this devastating disease.”
TACKLE’s results were published in The Lancet Respiratory Medicine.