{"id":1380,"date":"2022-02-16T15:00:02","date_gmt":"2022-02-16T08:00:02","guid":{"rendered":"https:\/\/news.eloqasia.com\/?p=1380"},"modified":"2022-02-22T15:01:16","modified_gmt":"2022-02-22T08:01:16","slug":"astrazeneca-to-supply-the-us-government-with-an-additional-one-million-doses-of-evusheld-long-acting-antibody-combination-for-the-prevention-of-covid-19","status":"publish","type":"post","link":"https:\/\/news.eloqasia.com\/?p=1380","title":{"rendered":"AstraZeneca to supply the US government with an additional one million doses of Evusheld long-acting antibody combination for the prevention of COVID-19"},"content":{"rendered":"

Builds on initial US government agreement, now totalling 1.7 million doses\u00a0<\/span><\/i><\/p>\n

Only antibody therapy authorized in the US for pre-exposure prophylaxis of <\/span><\/i>COVID-19 in people who are immunocompromised<\/span><\/i><\/p>\n

AstraZeneca today announced the US Department of Health and Human Services has finalized its agreement to purchase an additional one million doses of <\/span>Evusheld<\/span><\/i>TM<\/span> (150mg of tixagevimab co-packaged with 150mg of cilgavimab), a long-acting antibody combination for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised populations.\u00a0<\/span><\/p>\n

This agreement includes the 500,000 additional dose purchase <\/span>announced by the US government on January 12, 2022<\/span> and follows the government\u2019s initial agreement for the purchase of 700,000 doses of <\/span>Evusheld<\/span><\/i> which are already being administered at sites around the US, for a total of 1.7 million doses. The US government has indicated that it plans to distribute these additional doses to states and territories at no cost.\u00a0<\/span><\/p>\n

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: \u201cWith continued cases of COVID-19 across the US and in the wake of the Omicron variant, there remains a critical need to provide additional protection to immunocompromised patients who are most vulnerable to the virus. We are proud to continue playing a leading role in the fight against COVID-19 with <\/span>Evusheld<\/span><\/i>, the first long-acting antibody combination to receive emergency use authorization in the US for pre-exposure prophylaxis of COVID-19 and <\/span>the only antibody therapy authorized for this use<\/span>, that<\/span> shows <\/span>neutralizing activity against Omicron and all other variants of concern to date.\u201d\u00a0<\/span><\/p>\n

Nitin Kapoor, Chairman and General Director, AstraZeneca Vietnam and Asia Area Frontier Markets said: \u201cWe are heartened by this good news which means that many more vulnerable patients in the US will get the extra protection they need against COVID-19. We are working closely with the Vietnam Ministry of Health on the necessary steps to accelerate the regulatory approval process, with a hope that the amount of <\/span>Evusheld<\/span><\/i> sign Vietnam Vaccine JSC (VNVC) could soon meet the needs of immunocompromised groups in Vietnam.\u201d<\/span><\/p>\n

Multiple independent live and pseudovirus studies showed that <\/span>Evusheld<\/span><\/i> retains neutralizing activity against the Omicron variant and all tested SARS-CoV-2 variants of concern to date.<\/span>1-4<\/span> By combining two particularly potent antibodies with different and complementary activities against the virus, <\/span>Evusheld <\/span><\/i>was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants.\u00a0<\/span><\/p>\n

Evusheld<\/span> received Emergency Use Authorization (EUA) in the US on <\/span>December 8, 2021<\/span> for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine.\u00a0<\/span><\/p>\n

Evusheld<\/b><\/p>\n

Evusheld<\/span><\/i>, formerly known as AZD7442, is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Discovered by Vanderbilt University Medical Center and\u00a0<\/span>licensed to AstraZeneca in June 2020<\/span>, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein<\/span>5<\/span> and were optimized by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration;<\/span>6-8 <\/span>data from the Phase III PROVENT trial show protection lasting at least six months.<\/span>9<\/span> The reduced Fc receptor binding aims to minimize the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and\/or disease.<\/span>10 <\/span>Evusheld is delivered as an IM dose of 150mg tixagevimab and 150mg cilgavimab administered in two separate, consecutive injections.<\/span><\/p>\n

In December 2021, the FDA\u00a0 issued an <\/span>EUA<\/span> for the use of Evusheld for the pre-exposure prophylaxis (prevention) of COVID-19. It is the only antibody authorized in the US to prevent COVID-19 symptoms before virus exposure. Evusheld is also authorized for emergency use for prevention of COVID-19 in several other countries.\u00a0<\/span><\/p>\n

In August 2021, AstraZeneca <\/span>announced<\/span> that <\/span>Evusheld<\/span><\/i> demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 in the PROVENT trial; efficacy was 83% compared to placebo in a six-month analysis <\/span>announced<\/span> on November 18, 2021. In October 2021, AstraZeneca <\/span>announced<\/span> positive high-level results from the <\/span>Evusheld <\/span><\/i>TACKLE Phase III outpatient treatment trial. <\/span>Evusheld<\/span><\/i> is also being studied as a potential treatment for hospitalized COVID-19 patients as part of the National Institute of Health\u2019s <\/span>ACTIV-3 trial<\/span> and in an additional collaborator hospitalization treatment trial.<\/span><\/p>\n

Evusheld <\/span><\/i>is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.\u00a0<\/span><\/p>\n

Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.<\/span><\/p>\n

AstraZeneca<\/b><\/p>\n

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization 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. For more information, please visit <\/span>www.astrazeneca-us.com<\/span> and follow us on Twitter <\/span>@AstraZenecaUS<\/span>.<\/span><\/p>\n

References<\/b><\/p>\n

\u00a0ACTIV. National Center for Advancing Translational Sciences Open Data Portal. SARS-CoV-2 Variants & Therapeutics, All Variants Reported in vitro Therapeutic Activity. Available at: <\/span>https:\/\/opendata.ncats.nih.gov\/variant\/activity<\/span>. [Last accessed: February 2022].<\/span><\/p>\n

2<\/span> VanBlargan, L.A., Errico, J.M., Halfmann, P.J.\u00a0<\/span>et al.<\/span><\/i>\u00a0An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies.\u00a0<\/span>Nat Med<\/span><\/i>\u00a0(2022). https:\/\/doi.org\/10.1038\/s41591-021-01678-y.<\/span><\/p>\n

3<\/span> Dejnirattisai W, Huo J, Zhou D <\/span>et al. <\/span><\/i>SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses, <\/span>Cell<\/span><\/i>, Volume 185, Issue 3, 2022, Pages 467-484.e15,<\/span><\/p>\n

ISSN 0092-8674, https:\/\/doi.org\/10.1016\/j.cell.2021.12.046.<\/span><\/p>\n

4 <\/span>Takashita E, Kinoshita N, Yamayoshi <\/span>et al<\/span><\/i>. Efficacy of Antibodies and Antiviral Drugs against Covid-19 Omicron Variant. <\/span>N Engl J Med<\/span><\/i>. 2022 Jan 26. doi: 10.1056\/NEJMc2119407. Epub ahead of print. PMID: 35081300.<\/span><\/p>\n

5<\/span> Dong J, et al. Genetic and structural basis for recognition of SARS-CoV-2 spike protein by a two-antibody cocktail. bioRxiv. 2021; doi: 10.1101\/2021.01.27.428529.<\/span><\/p>\n

6<\/span> Robbie GJ, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013; 57 (12): 6147-53.<\/span><\/p>\n

7<\/span> 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): e01714-16.<\/span><\/p>\n

8<\/span> 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.<\/span><\/p>\n

9<\/span> AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention.\u00a0 Available at:\u00a0<\/span>https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2021\/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html<\/span>. [Last accessed: January 2022].<\/span><\/p>\n

10<\/span> van Erp EA, et al. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol. 2019; 10: 548.<\/span><\/p>\n

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Press release distributed by\u00a0EloQ Communications<\/a><\/em><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Builds on initial US government agreement, now totalling 1.7 million doses\u00a0 Only antibody therapy authorized in the US for pre-exposure prophylaxis of COVID-19 in people who are immunocompromised AstraZeneca today announced the US Department of Health and Human Services has Read More …<\/a><\/p>\n","protected":false},"author":76,"featured_media":1147,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[649,723,653,277,267,744,417,671,719,652,650],"yoast_head":"\nAstraZeneca to supply the US government with an additional one million doses of Evusheld long-acting antibody combination for the prevention of COVID-19 - EloQ's Newsroom<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/news.eloqasia.com\/?p=1380\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AstraZeneca to supply the US government with an additional one million doses of Evusheld long-acting antibody combination for the prevention of COVID-19 - 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