Evusheld long-acting antibody combination recommended for approval in the EU for the 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.”

Evusheld is authorised for use for pre-exposure prophylaxis (prevention) of COVID-19 in the US (emergency use), EU, Japan and many other countries. Evusheld is approved for treatment of those with risk factors for severe SARS-CoV-2 infection in Japan. Regulatory submissions are progressing for both prevention and treatment indications around the world.