AstraZeneca has submitted a request to the US Food and Drug
Administration (FDA) for an Emergency Use Authorization (EUA) for
AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of
symptomatic COVID-19.
If granted, AZD7442 would be the first LAAB to receive an EUA for
COVID-19 prevention. It is the first LAAB with Phase III data
demonstrating a statistically significant reduction in the risk of
developing symptomatic COVID-19 compared to placebo.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D,
AstraZeneca, said: “Vulnerable populations such as the immunocompromised
often aren’t able to mount a protective response following vaccination
and continue to be at risk of developing COVID-19. With this first
global regulatory filing, we are one step closer to providing an
additional option to help protect against COVID-19 alongside vaccines.
We look forward to sharing AZD7442 data for the treatment of COVID-19
later this year.”
In August, 2021, AstraZeneca announced high-level results from the PROVENT
pre-exposure prophylaxis trial which showed AZD7442 reduced the risk of
developing symptomatic COVID-19 by 77% (95% confidence interval (CI):
46, 90), compared to placebo. Importantly, the trial population included
people with co-morbidities and who may be in need of additional
protection from SARS-CoV-2 infection. Greater than 75% of participants
in PROVENT presented with co-morbidities associated with an increased
risk of severe disease or a reduced immune response to vaccination. The
trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.
AZD7442 was well-tolerated.
The EUA request filing includes safety and efficacy data from the PROVENT and STORM CHASER Phase III trials and the Phase I trial.
AZD7442 was optimised using AstraZeneca’s proprietary YTE half-life
extension technology which more than triples the durability of its
action compared to conventional antibodies1-4.
Preliminary ‘in vitro’ findings demonstrate that AZD7442 demonstrates
broad anti-COVID activity, and in particular neutralises recent
emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.5,6
Discussions regarding supply agreements for AZD7442 are ongoing with
the US Government as well as other governments around the world.
About AZD7442
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 licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein7
and were optimised 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 administration1-4; data from the Phase I trial show high neutralising antibody titres for at least nine months8.
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.9
AZD7442 is being studied in a comprehensive clinical trial programme
for both prevention and treatment of COVID-19 in over 9,000
participants. In the Phase III PROVENT trial, AZD7442 reduced the risk
of developing symptomatic COVID-19 by 77%, compared to placebo. The
trial included 5,197 participants in a 2:1 randomisation AZD7442 to
placebo. The primary analysis was based on 5,172 participants who did
not have SARS-CoV-2 infection at baseline. The LAAB was well tolerated
and preliminary analyses show adverse events were balanced between the
placebo and AZD7442 groups.
Other ongoing trials include TACKLE COVID-19,10 a Phase
III mild-to-moderate COVID-19 outpatient treatment trial, and
collaborator treatment trials in outpatient and hospitalised settings.
AZD7442 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.
Data published in Nature in
July 2020 showed that in preclinical experiments, the LAABs were able
to block the binding of the SARS-CoV-2 virus to host cells and protect
against infection in cell and animal models of disease.11
Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.
About 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.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
Print Page
Email to a Friend
