FDA Removes Evusheld’s EUA for COVID-19

AstraZeneca’s Evusheld is no longer authorized for use in the United States, according to a notice from the FDA. Evusheld had been granted an emergency use authorization (EUA) in December 2021 for COVID-19 pre-exposure prophylaxis. It is a combination of two long-acting antibodies — tixagevimab and cilgavimab — derived from B-cells donated by convalescent patients after SARS-CoV-2 infection.

Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants, including the omicron subvariants currently circulating in the United States. According to the most recent CDC modeling data, these variants are projected to be responsible for more than 90% of current infections in the United States. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants.

In a statement, AstraZeneca said it will continue to work with the FDA to assess and share relevant data regarding Evusheld and SARS-CoV-2 variants. Evusheld currently remains authorized in other countries where it is approved for COVID-19 pre-exposure prophylaxis and treatment, including the EU and Japan.

The company has initiated the SUPERNOVA program, a phase 1/3 trial to investigate the safety and efficacy of a next-generation long-acting antibody in COVID-19 pre-exposure prophylaxis in an immunocompromised population. In in vitro lab studies, the new long-acting antibody has been shown to neutralize all SARS-CoV-2 variants tested to date, including variants that have proved resistant to other monoclonal antibodies.

AstraZeneca is aiming to make the new long-acting antibody available in the second half of 2023.