AstraZeneca's Evusheld Gets CHMP Recommendation For EU Approval To Treat COVID-19

British drug major AstraZeneca plc (AZN.L,AZN) announced Friday that its Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union for the treatment of COVID-19.

The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended the drug to treat adults and adolescents aged 12 years and older weighing at least 40 kg, with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

The CHMP based its positive opinion on results from the TACKLE Phase III COVID-19 treatment trial. It was showed that one intramuscular or IM dose of Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo.

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.

Michel Goldman, Professor, Institute for Interdisciplinary Innovation in Healthcare, Université Libre de Bruxelles, and former Executive Director of the European Innovative Medicines Initiative, said, "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 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. It is already available in a majority of countries in Europe.

AstraZeneca said it expects the European Commission to shortly complete its review of the CHMP positive opinion to determine whether to grant marketing authorisation for treatment of COVID-19 in appropriate populations.

Evusheld is being developed with support from the US government, including federal funds from various agencies.

Evusheld, formerly known as AZD7442, was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. Under the licensing deal terms, AstraZeneca will pay single-digit royalties on future net sales.

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