BANGKOK- AstraZeneca has delivered a further 41,575 units (150mg each of tixagevimab and cilgavimab) of AZD7442, the COVID-19 long-acting antibody (LAAB) combination, to Thailand’s Department of Disease Control (DDC), part of the Ministry of Public Health in September 2022.
The latest batch of AZD7442 will be administered for pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents who are immunocompromised and unable to develop an adequate immune response to COVID‐19 vaccination, or for whom COVID-19 vaccination is not recommended, helping to address unmet needs in Thailand's ongoing fight against the virus.
Today’s delivery follows the successful rollout of the first 7,000 units of AZD7442 in July, among people with kidney failure. Another estimated 209,000 units will be supplied to Thailand by the end of this year, based on an agreement made between AstraZeneca and the DDC in July.
Mr James Teague, Country President, AstraZeneca (Thailand) Ltd., said: “The long-acting antibody combination provides vulnerable people in Thailand, such as the immunocompromised who may not be adequately protected by vaccination alone, another important COVID-19 prevention option. Supporting the Ministry of Public Health’s mass immunisation programme is our highest priority, but we are pleased to now also deliver increased options for those who live at particularly high risk of Omicron-related severe outcomes, leaving no one behind.”
AZD7442 was granted conditional marketing authorisation in June 20221 by the Food and Drug Administration in Thailand for the prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg, no matter their COVID-19 vaccination status. The Department of Disease Control is planning to use the medicine with the “607 population”, the group which is most vulnerable to the virus or not recommended to undergo COVID-19 vaccination.
Now in use in over 30 countries for pre-exposure prophylaxis, AZD7442 is available in the US, Canada, France, Germany, Spain, Australia, New Zealand, China, Egypt, Malaysia, South Korea and Vietnam, among others. Last week in Japan, AZD7442 was approved for both the prevention and treatment of COVID-19 for certain populations Regulatory filings continue to progress around the world for both prevention and treatment indications of COVID-19.
AZD7442
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 protein2 and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding.3 The half-life extension more than triples the durability of its action compared to conventional antibodies;4-6 data from the Phase III PROVENT trial show protection lasting six months.5 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.7
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.
Media Contact
Pucharapan Holim, Corporate Affairs Manager
Email: pucharapan.holim@astrazeneca.com
Tel. +66 (0) 86 999 8587
References
1. Thailand Food and Drug Administration, Ministry of Health http://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/pop-up_drug_ex.aspx?Newcode=U1DR2C1072650000511C. (Last accessed September 2022).
2. 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.
3. 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.
4. 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.
5. 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).
6. 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.
7. van Erp EA, et al. Fc-Mediated Antibody Effector Functions During Respiratory Syncytial Virus Infection and Disease. Front Immunol. 2019;10 (MAR).
TH-11904
Expiration Date: 9/29/2024