AstraZeneca Evusheld recommended for approval in EU for treatment of 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. 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.

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: "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."

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: "Evusheld has already made an important difference around the world helping prevent COVID-19 infections in vulnerable populations who can't mount an adequate response to COVID-19 vaccination. This positive CHMP opinion underscores Evusheld's potential as a COVID-19 treatment for patients at increased risk of progressing to severe disease."

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.

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.

"AstraZeneca anticipates that the European Commission will shortly complete its review of the CHMP positive opinion to determine whether to grant marketing authorisation for treatment of COVID-19 in appropriate populations," the company stated.

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