Legal status
In October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of tixagevimab/cilgavimab, which is being developed by AstraZeneca AB, for the prevention of COVID-19 in adults.[25] It was approved for medical use in the European Union in March 2022.[12]
Also in October 2021, AstraZeneca requested emergency use authorization for tixagevimab/cilgavimab to prevent COVID-19 from the US Food and Drug Administration (FDA).[26]
In November 2021, Bahrain authorized it for emergency use.[27]
In December 2021, the US FDA granted emergency use authorization (EUA) of this combination to prevent COVID-19 (before exposure) in people with weakened immunity or who cannot be fully vaccinated due to a history of severe reaction to coronavirus vaccines.[28][29][30] and in certain people aged 12 years of age and older weighing at least 40 kilograms (88 lb).[20] The product is only authorized for those individuals who are not infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2.[20][31] The EUA was revoked in January 2023.[32]
In March 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Evusheld, intended for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kilograms (88 lb).[33] The applicant for this medicinal product is AstraZeneca AB.[33] It has since been granted approval for use in the UK[34][35] and in the European Union.[12][36]
In January 2023, the FDA revised the EUA for Evusheld to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%.[32] Based on this revision, Evusheld is not authorized for use in the US.[32]
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