FDA Pulls EUA Granted to AstraZeneca's (AZN) Evusheld
FDA withdrew AstraZeneca's Evusheld authorization in the U.S. due to its inefficacy against Omicron subvariants, responsible for over 90% of current infections. AstraZeneca's shares rose 11.3% this year. Evusheld remains authorized in Europe and Japan. AstraZeneca is developing a next-generation antibody for COVID-19, aiming for a 2023 launch.
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FDA has temporarily revoked emergency use authorization for AstraZeneca's EVUSHELD for COVID-19 pre-exposure prophylaxis in the US due to its ineffectiveness against prevalent SARS-CoV-2 variants. AstraZeneca is developing a next-generation antibody, with trials underway, aiming for availability in late 2023. EVUSHELD remains authorized in other countries for COVID-19 prevention and treatment.
FDA has paused AstraZeneca’s Evusheld for COVID-19 prevention in the US due to its ineffectiveness against prevalent SARS-CoV-2 variants. AstraZeneca is testing a new long-acting antibody, aiming for 2023 availability, to protect immunocompromised individuals against all tested variants.
FDA withdrew AstraZeneca's Evusheld authorization in the U.S. due to its inefficacy against Omicron subvariants, responsible for over 90% of current infections. AstraZeneca's shares rose 11.3% this year. Evusheld remains authorized in Europe and Japan. AstraZeneca is developing a next-generation antibody for COVID-19, aiming for a 2023 launch.