2022-09-20| Trials & Approvals

AstraZeneca’s Treatment for COVID-19 Wins European Approval

by Max Heirich
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On September 20, the European Commission (EC) approved AstraZeneca’s antibody combination, Evusheld (tixagevimab and cilgavimab). The long-acting combination treats adolescents, twelve and up, and adults with COVID-19 at risk of progressing to severe COVID-19. The EC based its approval on the TACKLE Phase 3 COVID-19 treatment trial.

Related Article: The COVID-19 Pandemic: Is Omicron the Last Variant?

Evusheld’s History And Treatment of COVID

Originally known as AZD7442, Vanderbilt University Medical Center originally discovered Evusheld in June 2020. They licensed it to AstraZeneca for further development. Derived from B-cells donated by recovering COVID-19 patients, the antibodies bind to distinct sites on the SARS-CoV-2 spike protein. As a result, Evusheld neutralizes the virus’ infectability of healthy cells. 

At first, Evusheld gained approval as a preventative treatment for COVID-19. The United States Food and Drug Administration granted Euvsheld an Emergency Use Authorization (EUA) for the prevention of COVID-19 in December 2021. The authorization required individuals to either have moderate to severely compromised immune systems due to a medical condition or medications or a history of severe adverse reactions to a COVID-19 vaccine. The EC later granted a similar approval in March of this year, citing Evusheld’s protection against Omivron strains proven in the PROVENT Phase 3 trial.

However, AstraZeneca is now seeking Evusheld’s approval as a treatment for current COVID-19 infections. Gaining their first approval for this use in Japan, EC accepted AstraZeneca’s expanded use for their antibody. 

European Commission Accepts EMA’s Positive Opinion

The EC accepted the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use’s (CHMP) positive opinion for the approval of Evusheld as a COVID-19 treatment. The basis of the recommendation and approval is the TACKLE Phase 3 Study.

The TACKLE study assessed the safety and efficacy of Evusheld compared to placebo for the treatment of mild-to-moderate COVID-19. The results, published in The Lancet Respiratory Medicine, showed a 50% reduction in progression to serve COVID-19 compared to the placebo. 

On the approval, Iskra Reic, Executive Vice President, Vaccines and Immune Therapies at AstraZeneca, said, “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.”

Going forward, AstraZeneca will likely continue seeking approvals for Evusheld as a treatment for COVID-19, particularly in countries where the antibody is already approved for the prevention of the virus. 

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