Tixagevimab/cilgavimab, sold under the brand nameEvusheld, is a combination of twohuman monoclonal antibodies,tixagevimab (AZD8895) andcilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2[15][16] used to preventCOVID-19.[17] It is being developed by British-Swedish multinationalpharmaceutical andbiotechnology companyAstraZeneca.[18][19] It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession).[20]
In 2020, researchers atVanderbilt University Medical Center discovered particularly potentmonoclonal antibodies, isolated fromCOVID-19 patients infected with a SARS-CoV-2 circulating at that time. Initially designated COV2-2196 and COV2-2130, antibody engineering was used to transfer their SARS-CoV-2 binding specificity to IgG scaffolds that would last longer in the body, and these engineered antibodies were named AZD8895 (tixagevimab) and AZD1061 (cilgavimab), respectively (and the combination was called AZD7442).[21]
To evaluate the potential of the antibodies as monoclonal antibody based prophylaxis (prevention), the 'Provent'clinical trial enrolled 5,000 high risk but not yet infected individuals and monitored them for 15 months.[22][23] The trial reported that those receiving the cocktail showed a 77% reduction insymptomatic COVID-19 and that there were no severe cases or deaths. AstraZeneca also found that the antibody cocktail "neutralizes recent emergentSARS-CoV-2 viral variants" including theDelta variant,[19] and theOmicron variant.[24]
In contrast to pre-exposure prophylaxis, the Storm Chaser study of already-exposed people (post-exposure prophylaxis) did not meet itsprimary endpoint, which was prevention of symptomatic COVID-19 in people already exposed. AZD7442 was administered to 1,000 volunteers who had recently been exposed to COVID.[22]
In October 2021, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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]
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]
^ab"Evusheld: Pending EC decision".European Medicines Agency (EMA). 25 March 2022.Archived from the original on 25 March 2022. Retrieved25 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
"Tixagevimab".Drug Information Portal. U.S. National Library of Medicine. Archived fromthe original on 15 October 2021.
Clinical trial numberNCT04625972 for "Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post-exposure Prophylaxis of COVID-19 in Adults (STORM CHASER)" atClinicalTrials.gov
Clinical trial numberNCT04625725 for "Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT)" atClinicalTrials.gov
This article incorporates text from this source, which is in thepublic domain.
.svg)
