Clinical trials showed LAAB reduced risk of severe COVID-19 or death by 88% for patients who received treatment within three days of symptom onset
BANGKOK - AstraZeneca's AZD7442 (tixagevimab and cilgavimab), a long-acting antibody combination (LAAB), has been granted conditional marketing approval in Thailand for the treatment of mild to moderate COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg).
This approval is in addition to the conditional marketing approval granted to LAAB by Thailand’s Food and Drug Administration in June 2022, for preventing COVID-19 in a broad population of adults and adolescents, regardless of vaccination status. AstraZeneca finalised an agreement in July with the Thai government to supply the country with 257,500 doses of LAAB.
Mr James Teague, Country President, AstraZeneca (Thailand) Ltd., said: “Today marks an especially important milestone as LAAB is now the only antibody combination authorised for both COVID-19 prevention and treatment in Thailand. Despite recent lifts in restrictions, many people remain at risk of poor outcomes from severe COVID-19, and LAAB is a much-needed option that will not only help protect against severe symptoms of COVID-19, but also prevent severe disease and death in those who do become infected.”
According to data from the TACKLE Phase III outpatient treatment trial, a 600mg IM dose of LAAB significantly reduced the relative risk of progressing to severe COVID-19 or death (from any cause) by 50% (95% confidence interval [CI] 15, 71; p=0.010) through day 29 compared to placebo in non-hospitalised patients with mild-to-moderate COVID-19 who were symptomatic for seven days or less, the trial’s primary endpoint1.
In pre-specified analyses of participants who received treatment within three days of symptom onset, LAAB reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo (95% CI 9, 98), and the risk reduction was 67% (95% CI 31, 84) when participants received LAAB within five days of symptom onset1.
According to data from the University of Oxford2, the antibody combination retains its neutralising activity against Omicron subvariants, BA.4 and BA.5 (both dominant in Thailand), and other dominant variants of concern.
LAAB has been approved in Japan and the EU for both prevention and treatment of symptomatic disease caused by SARS-CoV-2 infection and has conditional marketing authorisation in Great Britain for prevention of COVID-19. It is also authorised for emergency prevention use in the US and is being supplied in several other countries around the world.
AZD7442 or LAAB
AZD7442 is derived from B-cells donated by individuals previously infected with the SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein3 and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding.4 The half-life extension more than triples the durability of its action compared to conventional antibodies;5-7 data from the Phase III PROVENT trial show protection lasting six months.6 The reduced Fc receptor binding aims to minimise the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.8
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
References
1. Montgomery H, et al. Efficacy and Safety of Intramuscular Administration of AZD7442 (Tixagevimab/Cilgavimab) for Early Outpatient Treatment of COVID-19: The TACKLE Phase 3 Randomised Controlled Trial. Lancet Respir Med. Published online June 7, 2022. doi.org/10.1016/S2213-2600(22)00180-1.
2. AstraZeneca news release. Evusheld long-acting antibody combination retains neutralising activity against Omicron variants BA.4 and BA.5, according to new study from University of Oxford. Available at: https://www.astrazeneca.com/media-centre/medical-releases/evusheld-long-acting-antibody-combination-retains-neutralising-activity-omicron-variants-ba4-ba5-according-new-study-university-oxford.html. [Last accessed: June 2022].
3. Dong J, et al. Genetic and Structural Basis for SARS-CoV-2 Variant Neutralization by a Two-Antibody Cocktail. Nat Microbiol. 2021;6(10):1233-1244. doi:10.1038/s41564-021-00972-2.
4. Loo YM, et al. AZD7442 Demonstrates Prophylactic and Therapeutic Efficacy in Non-Human Primates and Extended Half-Life in Humans. Sci Transl Med. 2022;14(635):eabl8124.
5. Robbie GJ, et al. A Novel Investigational Fc-Modified Humanized Monoclonal Antibody, Motavizumab-YTE, Has an Extended Half-Life in Healthy Adults. Antimicrobial Agents and Chemotherapy. 2013;57(12):6147. doi:10.1128/AAC.01285-13.
6. Griffin MP, et al. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017;61(3).
7. Domachowske JB, et al. Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-Life Single-Dose Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018;37(9):886-892.
8. van Erp EA, et al. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019;10 (MAR).
TH-12254
Expiration Date: 11/2/2024