|
(Heavy chain)
QMQLVQSGPE VKKPGTSVKV SCKASGFTFM SSAVQWVRQA RGQRLEWIGW IVIGSGNTNY AQKFQERVTI TRDMSTSTAY MELSSLRSED TAVYYCAAPY CSSISCNDGF DIWGQGTMVT VSSASTKGPS VFPLAPSSKS TSGGTAALGC LVKDYFPEPV TVSWNSGALT SGVHTFPAVL QSSGLYSLSS VVTVPSSSLG TQTYICNVNH KPSNTKVDKR VEPKSCDKTH TCPPCPAPEF EGGPSVFLFP PKPKDTLYIT REPEVTCVVV DVSHEDPEVK FNWYVDGVEV HNAKTKPREE QYNSTYRVVS VLTVLHQDWL NGKEYKCKVS NKALPASIEK TISKAKGQPR EPQVYTLPPS REEMTKNQVS LTCLVKGFYP SDIAVEWESN GQPENNYKTT PPVLDSDGSF FLYSKLTVDK SRWQQGNVFS CSVMHEALHN HYTQKSLSLS PGK (Light chain) EIVLTQSPGT LSLSPGERAT LSCRASQSVS SSYLAWYQQK PGQAPRLLIY GASSRATGIP DRFSGSGSGT DFTLTISRLE PEDFAVYYCQ HYGSSRGWTF GQGTKVEIKR TVAAPSVFIF PPSDEQLKSG TASVVCLLNN FYPREAKVQW KVDNALQSGN SQESVTEQDS KDSTYSLSST LTLSKADYEK HKVYACEVTH QGLSSPVTKS FNRGEC (Disulfide bridge: H22-H96, H101-H106, H150-H206, H216-L216, H232-H’232, H235-H’235, H267-H327, H373-H431, H’22-H’96, H’101-H’106, H’150-H’206, H’226-L’216, H’267-H’327, H’373-H’431, L23-L89, L136-L196, L’23-L’89, L’136-L’196) |
Tixagevimab
FDA 2021, 2021/12/8
ANTI VIRAL, CORONA VIRUS, PEPTIDE
Monoclonal antibody
Treatment and prevention of SARS-CoV-2 infection
| Formula |
C6488H10034N1746O2038S50
|
|---|---|
| CAS |
2420564-02-7
|
| Mol weight |
146704.817
|
- 2196
- AZD-8895
- AZD8895
- COV2-2196
- Tixagevimab
- Tixagevimab [INN]
- UNII-F0LZ415Z3B
- WHO 11776
- OriginatorVanderbilt University
- DeveloperAstraZeneca; INSERM; National Institute of Allergy and Infectious Diseases
- ClassAntivirals; Monoclonal antibodies
- Mechanism of ActionVirus internalisation inhibitors
- RegisteredCOVID 2019 infections
- 24 Dec 2021Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by AstraZeneca
- 16 Dec 2021Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by AstraZeneca
- 10 Dec 2021Registered for COVID-2019 infections (In the elderly, Prevention, In adults) in USA (IM) – Emergency Use Authorization
Tixagevimab/cilgavimab is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2[4][5] used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca.[6][7] It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession).[2]
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Development
In 2020, researchers at Vanderbilt University Medical Center discovered particularly potent monoclonal antibodies, isolated from COVID-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 and AZD1061, respectively (and the combination was called AZD7442).[8]
To evaluate the antibodies’ potential 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.[9][10] The trial reported that those receiving the cocktail showed a 77% reduction in symptomatic COVID-19 and that there were no severe cases or deaths. AstraZeneca also found that the antibody cocktail “neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta variant“.[7]
In contrast to pre-exposure prophylaxis, the Storm Chaser study of already-exposed people (post-exposure prophylaxis) did not meet its primary 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.[9]
Regulatory review
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.[11]
Also in October 2021, AstraZeneca requested Emergency Use Authorization for tixagevimab/cilgavimab to prevent COVID-19 from the U.S. Food and Drug Administration (FDA).[12][13]
On 14 November 2021, Bahrain granted emergency use authorization.[14]
On 8 December 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization 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.[15] The FDA issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain people aged 12 years of age and older weighing at least 40 kilograms (88 lb).[2] The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2.[2]
References
- ^ “Evusheld- azd7442 kit”. DailyMed. Retrieved 4 January 2022.
- ^ Jump up to:a b c d “Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals”. U.S. Food and Drug Administration (FDA) (Press release). 8 December 2021. Retrieved 9 December 2021.
This article incorporates text from this source, which is in the public domain. - ^ O’Shaughnessy, Jacqueline A. (20 December 2021). “Re: Emergency Use Authorization 104” (PDF). Food and Drug Administration. Letter to AstraZeneca Pharmaceuticals LP | Attention: Stacey Cromer Berman, PhD. Archived from the original on 29 December 2021. Retrieved 18 January 2022.
- ^ “IUPHAR/BPS Guide to PHARMACOLOGY”. IUPHAR. 27 December 2021. Retrieved 27 December 2021.
- ^ “IUPHAR/BPS Guide to PHARMACOLOGY”. IUPHAR. 27 December 2021. Retrieved 27 December 2021.
- ^ Ray, Siladitya (21 August 2021). “AstraZeneca’s Covid-19 Antibody Therapy Effective In Preventing Symptoms Among High-Risk Groups, Trial Finds”. Forbes. ISSN 0015-6914. Archived from the original on 21 August 2021. Retrieved 18 January 2022.
- ^ Jump up to:a b Goriainoff, Anthony O. (20 August 2021). “AstraZeneca Says AZD7442 Antibody Phase 3 Trial Met Primary Endpoint in Preventing Covid-19”. MarketWatch. Archived from the original on 21 August 2021. Retrieved 18 January 2022.
- ^ Dong J, Zost SJ, Greaney AJ, Starr TN, Dingens AS, Chen EC, et al. (October 2021). “Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail”. Nature Microbiology. 6 (10): 1233–1244. doi:10.1038/s41564-021-00972-2. ISSN 2058-5276. PMC 8543371. PMID 34548634.
- ^ Jump up to:a b Haridy, Rich (23 August 2021). ““Game-changing” antibody cocktail prevents COVID-19 in the chronically ill”. New Atlas. Retrieved 23 August 2021.
- ^ “AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19”. AstraZeneca (Press release). 20 August 2021. Retrieved 15 October 2021.
- ^ “EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)”. European Medicines Agency. 14 October 2021. Retrieved 15 October 2021.
- ^ “AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US”. AstraZeneca US (Press release). 5 October 2021. Retrieved 15 October 2021.
- ^ “AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US”. AstraZeneca (Press release). 5 October 2021. Retrieved 15 October 2021.
- ^ Abd-Alaziz, Moaz; Elhamy, Ahmad (14 November 2021). Macfie, Nick (ed.). “Bahrain authorizes AstraZeneca’s anti-COVID drug for emergency use”. Reuters. Archived from the original on 23 November 2021. Retrieved 18 January 2022.
- ^ Mishra, Manas; Satija, Bhanvi (8 December 2021). Dasgupta, Shounak (ed.). “U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail”. Reuters. Archived from the original on 13 January 2022. Retrieved 18 January 2022.
External links
“Tixagevimab”. Drug Information Portal. U.S. National Library of Medicine.
- “Cilgavimab”. Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT04625972 for “Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post-exposure Prophylaxis of COVID-19 in Adults (STORM CHASER)” at ClinicalTrials.gov
- Clinical trial number NCT04625725 for “Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT)” at ClinicalTrials.gov
Tixagevimab (teal, right) and cilgavimab (purple, left) binding the spike protein RBD. From PDB: 7L7E.
|
|
| Combination of | |
|---|---|
| Tixagevimab | Monoclonal antibody |
| Cilgavimab | Monoclonal antibody |
| Clinical data | |
| Trade names | Evusheld |
| Other names | AZD7442 |
| License data |
|
| Routes of administration |
Intramuscular |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
| Clinical data | |
|---|---|
| Drug class | Antiviral |
| ATC code |
|
| Identifiers | |
| CAS Number |
|
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6488H10034N1746O2038S50 |
| Molar mass | 146706.82 g·mol−1 |
| Clinical data | |
|---|---|
| Drug class | Antiviral |
| ATC code |
|
| Identifiers | |
| CAS Number |
|
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6626H10218N1750O2078S44 |
| Molar mass | 149053.44 g·mol−1 |
/////////////////Tixagevimab, ANTI VIRAL, CORONA VIRUS, PEPTIDE, Monoclonal antibody, SARS-CoV-2 , WHO 11776, 2196, AZD-8895, AZD 8895, COV2-2196, FDA 2021, APPROVALS 2021