Swissmedic has granted marketing authorization for Switzerland’s first drug-based preventive treatment for COVID-19. The antibody combination of tixagevimab and cilgavimab (AZD7442) will be covered subject to certain conditions by the Federal Government and health insurers.
The preventive treatment is intended for at-risk patients unable to build up an adequate immune response to COVID-19 despite multiple vaccinations. Immunosuppressed patients with cancer, transplants or rheumatoid arthritis are particularly affected. Compared to the general population, immunocompromised patients are up to three more likely to be hospitalized and twice as likely to die.[i],[ii]. There are about 200,000 immunocompromised patients in Switzerland.[iii],[iv],[v],[vi] Experts estimate that there are about 10,000 high-risk patients throughout Switzerland.[vii]
Simon Weinmann, Head of the Immunization and Immunotherapy Department at AstraZeneca, says: “We are very happy about Swissmedic’s decision and will continue to work closely with the Federal Government, cantons, and physicians to ensure that COVID-19 prophylaxis is available to all affected patients.”
The Federal Government has so far ordered about 5,000 doses of the tixagevimab plus cilgavimab antibody combination. The conditions for dispensing the treatment and covering its costs have been established by the Swiss Society for Infectious Diseases (SSI).
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Daniel Widrig, Corporate Affairs Director
+41 (0) 41 725 75 75; Media.Switzerland@astrazeneca.com
Further information
Marketing authorization from Swissmedic
Swissmedic has granted temporary marketing authorization for the tixagevimab plus cilgavimab antibody combination (AZD7442) in a fast-track process. The treatment is indicated for pre-exposure preventive treatment for COVID-19 in adults and adolescents (aged 12 years and over and with a body mass of at least 40 kg, 1) who are not capable of developing an adequate immune response to the SARS-CoV-2 vaccination and 2) who are not currently infected with SARS-CoV-2 and have had no recent contact with anyone infected with SARS-CoV-2. New applications are currently under review (for treatment after COVID exposure and for dose adjustments during preventive use).[viii]
The antibody combination tixagevimab and cilgavimab (AZD7442)
The antibody treatment (AZD7442) is a combination of two long-acting antibodies (also known as “LAABs”) - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from the B-cells of patients convalescing after a SARS-CoV2 infection. Human monoclonal antibodies were discovered at Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.
The antibodies bind to different sites on the SARS-CoV2 spike protein[ix] and have been optimized by AstraZeneca to have a prolonged half-life and reduced binding to the Fc receptor and complement C1q. The longer half-life prolongs the duration of action compared with conventional antibodies. [x],[xi],[xii] Initial data from the ongoing PROVENT phase III prevention study indicate that the protection lasts at least six months.[xiii] The reduced binding to the Fc receptor should minimize the risk of antibody-dependent exacerbation of the condition, a process in which virus-specific antibodies cause the infection and/or disease to progress instead of inhibiting it.[xiv] AZD7442 is administered as an intramuscular injection.
In August 2021 AstraZeneca announced that AZD7442 showed a statistically significant reduction in the risk of developing symptomatic COVID-19 in the PROVENT study; efficacy was 83% versus placebo in a 6-month analysis, as was published on 18 November 2021. In October 2021, AstraZeneca published the results of the TACKLE phase III outpatient treatment study. In the TACKLE phase III outpatient treatment study, AZD7442 reduced the risk of developing a severe COVID-19 infection or dying (regardless of cause) among non-hospitalized patients with mild to moderate COVID-19 who had been symptomatic for seven days or less (the primary endpoint)[xv]; the risk was reduced by 50% versus placebo, by 67% when patients were treated within five days of symptom onset, and by 88% when treatment was administered within three days.15 90% of the participants in the TACKLE study were at high risk of developing a severe COVID-19 infection.15
AZD7442 is also being studied as a potential treatment for inpatient COVID-19 patients in the ACTIV-3 study of the National Institutes of Health, and in a further study being conducted by cooperation partners.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on research, development, and commercialization of prescription medications. Its most important therapeutic areas are oncology, biopharmaceuticals (including cardiovascular, renal and metabolism, and respiratory and immunology), and rare diseases. AstraZeneca is based in Cambridge, UK, and operates in over 100 countries.
AstraZeneca in Switzerland
350 employees are responsible for coordinating local and international business operations in Switzerland. The most important therapeutic areas are oncology, biopharmaceuticals (including cardiovascular, renal and metabolism, and respiratory diseases, as well as immunology), and rare diseases. To reach climate goals ahead of schedule, AstraZeneca is working tirelessly to reduce CO2 emissions and waste. With its “Ambition Zero Carbon” strategy, the company has set itself the goal of carbon-free business operations. In 2021, AstraZeneca Switzerland was rated by its employees for the fourth time in a row as an outstanding employer and honored with the external label “Great Place to Work®”.
Find out more at: astrazeneca.ch
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[i] Fisher AM, Schlauch D, Mulloy M, et al. Outcomes of COVID-19 in hospitalized solid organ trans-plant recipients compared to a matched cohort of non-transplant patients at a national healthcare system in the United States. Clin Transplant. 2021;35:e14216.
[ii] Suleyman G, Fadel R, Brar I, et al. Risk factors associated with hospitalization and death in COVID-19 breakthrough infections. Open Forum Infect Dis. 2022;9:ofac116.
[iii] In House Data, AstraZeneca Pharmaceuticals LP. Up to 2% of the Targeted Patients for LAAB Treatment Are Immunocompromised. 2021. REF-129335.
[iv] Harpaz R, Dahl RM, Dooling KL. Prevalence of immunosuppression among US adults, 2013. JAMA. 2016;316:2547-2548.
[v] Centers for Disease Control and Prevention. COVID-19 vaccines for people who are moderately or severely immunocompromised. Centers for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html. Updated May 20, 2022. Accessed May 20, 2022.
[vi] Abbasi J. Researchers tie severe immunosuppression to chronic COVID-19 and virus variants. JAMA. 2021;325:2033-2035.
[vii] Position paper on the use of monoclonal antibodies against SARS-CoV-2 as passive immunisation treatments in severely immunocompromised persons in Switzerland
https://www.bag.admin.ch/dam/bag/de/dokumente/biomed/heilmittel/COVID-19/positionspapier_praeexpositionsprophylaxe_pdf.pdf.download.pdf/220421_position%20paper_mAK%20Pr%C3%A4v_COVID_final_de.pdf [last accessed: September 2022]
[viii] Swissmedic Fachinformation (Information for Healthcare Professionals), AstraZeneca Data on File, shortly to be published under: https://www.swissmedicinfo.ch/.
[ix] 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.
[x] 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.
[xi] 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.
[xii] 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.
[xiii] AstraZeneca news release. New analyses of two AZD7442 COVID-19 trials in high-risk populations confirm robust efficacy and long-term prevention. Available at: 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. [Last accessed: December 2021].