AstraZeneca on Friday announced that its Evusheld (tixagevimab and cilgavimab, formerly), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19. According to the company, this is for those people who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.
“The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the TACKLE Phase III COVID-19 treatment trial which showed one intramuscular (IM) dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo. Evusheld treatment earlier in the disease course led to more favourable outcomes,” the company stated on Friday.
The pharma major also stated that TACKLE was conducted in non-hospitalised adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less. 90% of trial participants were at high risk of progression to severe COVID-19 due to co-morbidities or age. Evusheld was generally well tolerated in the trial, the company claimed.
“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 hospitalisation. For high-risk patients, there is a major need for tolerable and effective therapies that can be used to block COVID-19 progression and prevent poor outcomes. As we head into the autumn and winter months when COVID-19 infections may rise, Evusheld represents an important new treatment option to protect patients infected with the SARS-CoV-2 virus against severe disease and death,” Michel Goldman, M.D., Ph.D., Professor, Institute for Interdisciplinary Innovation in Healthcare, Université Libre de Bruxelles, and former Executive Director of the European Innovative Medicines Initiative, said in a statment on Friday.
According to the company, the recommended dose of Evusheld for treatment in the EU is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential IM injections.
“Evusheld been shown to retain in vitro neutralisation of Omicron BA.5, which is currently the dominant SARS-CoV-2 variant in Europe. Real-world evidence generated to date has demonstrated significantly lower rates of symptomatic COVID-19 and/or hospitalisation/death for immunocompromised patients receiving Evusheld compared to control arms. This includes real-world evidence collected while Omicron BA.5, BA.4, BA.2, BA.1 and BA.1.1 were circulating,” the company added.
Meanwhile, Evusheld was granted marketing authorisation in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents earlier this year and is already available in a majority of countries in Europe.