AstraZeneca has completed the studies that support the first regulatory filings for the transition of Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) to an innovative, next-generation propellant with 99.9% lower Global Warming Potential than propellants used in currently available inhaled medicines.[1]

Breztri is a triple-combination therapy for chronic obstructive pulmonary disease (COPD) and will be the first medicine in AstraZeneca's portfolio of pressurised-metered dose inhalers (pMDIs) to transition to the new propellant. Clinical programmes for the transition of AstraZeneca's wider pMDI portfolio to the new propellant are underway. While pMDIs contribute less than 0.04% of global greenhouse gas emissions, AstraZeneca is committed to significantly reducing this burden.[2]

Omar Usmani, Professor of Respiratory Medicine at Imperial College London and co-ordinating study investigator, said: "Respiratory medicines delivered in pressurised metered-dose inhalers are essential for millions of people living with respiratory disease worldwide, including specific vulnerable populations such as children and the elderly. Transitioning to inhaled respiratory medicines using a propellant with a carbon footprint similar to non-propellant-based inhaled medicines is critical for planetary health in reducing the carbon footprint, while addressing patient needs and healthcare professionals' ability to achieve optimal clinical outcomes."

Sharon Barr, Ph.D, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Essential, life-saving medicines delivered to patients by pressurised-metered dose inhalers are the most used treatments in respiratory care and ensuring access to them based on clinical need is critical to optimising patient outcomes. We have now completed the studies that support the first regulatory filings to transition Breztri to the innovative propellant with near-zero Global Warming Potential as part of our commitment to patients and the planet."

Results from the studies for Breztri with the next-generation propellant will be shared with regulatory authorities, with first submissions in Europe, the UK and China expected before the end of 2024.

AstraZeneca is studying the medical grade version of HFO-1234ze, a next generation propellant, for use in its portfolio of pMDI medicines. Data from two Phase I studies of systemic and lung bioequivalence were presented at the American Thoracic Society (ATS) 2024 Conference in May, and results from the Phase IIIb bronchospasm study are being presented at the European Respiratory Society (ERS) Congress 2024.[3-5 ]Additional data will be presented at forthcoming medical meetings.

Chronic respiratory diseases including COPD and asthma affect hundreds of millions of people around the world.[6] Respiratory inhaled medicines delivered by pMDIs account for 78% of inhaler usage globally.[7] Reducing the carbon impact of pMDIs is a key product-related element of AstraZeneca's Ambition Zero Carbon strategy, alongside the company's commitment to improving patient outcomes.[8] Implementing evidence-based guidelines into clinical practice can reduce exacerbations and hospitalisations, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care.[9][-11]

Notes

Breztri/Trixeo Aerosphere
Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered via the Aerosphere pressurised metered-dose inhaler. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 50 countries worldwide including the US, EU, China, Japan, and is currently being studied in Phase III trials for asthma.

AstraZeneca's Collaboration with Honeywell  
Developed and patented by Honeywell, the medical grade version of HFO-1234ze is a critical propellant to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 (https://www.astrazeneca.com/media-centre/press-releases/2022/astrazeneca-progresses-ambition-zero-carbon-programme-with-honeywell-partnership-to-develop-next-generation-respiratory-inhalers.html) its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant.

Ambition Zero Carbon
Through its Ambition Zero Carbon (https://www.astrazeneca.com/sustainability/environmental-protection/ambition-zero-carbon.html) strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. The Company is on track to reduce greenhouse gas (GHG) emissions from its global operations and fleet (Scope 1 and 2) by 98% by 2026 (from a 2015 baseline). AstraZeneca aims to halve its entire value chain footprint (Scope 3) by 2030, on the way to a 90% absolute emissions reduction (from a 2019 baseline) by 2045 at the latest. By 2030, the Company will become carbon negative for all residual emissions. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard.

AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca (https://www.astrazeneca.com/)
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's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the Company on social media @AstraZeneca (https://gateway.zscalertwo.net/auD?origurl=https:%2f%2fwww.linkedin.com%2fcompany%2fastrazeneca&_ordtok=Mkk3WV5DBDPmQrD4F5MGdGDMZR)

Contacts
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References

1. AstraZeneca Pharmaceuticals. Data on File. Global Warming Potential of HFO-1234ze. (ID: REF-140251).
2. Emeryk AW, Sosnowski T, Kupczyk M, et al. Impact of inhalers used in the treatment of respiratory diseases on global warming. Adv Respir Med 2021;89:427-438.
3. Shah M, Aurivillius M, Raphiou I, et al. Systemic exposure bioequivalence of budesonide/ glycopyrrolate/ formoterol fumarate with the potential next generation propellant hydrofluoroolefin-1234ze versus hydrofluoroalkane-134a in healthy adults. [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2024 (17-22 May).
4. Raphiou I, Aurivillius M, Petullo D, et al. Lung exposure bioequivalence with budesonide/glycopyrrolate/formoterol fumarate with the next generation propellant hydrofluoroolefin-1234ze versus hydrofluoroalkane-134a in healthy adults: a charcoal block study. [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2024 (17-22 May).
5. Bell A, Jassal M, Xu J, et al. A randomized, double-blind, crossover study of change in post-dose lung function with a new generation propellant for metered dose inhalers in patients with asthma. [Poster Session]. Presented at the European Respiratory Society Congress 2024 (7-11 September).
6. GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun; 8 (6): 585-596.
7. Bell J, Tewari SG, Budgen N, et al. An Assessment Of Pressurized Metered-dose Inhaler Use In Countries In Europe And The Rest Of The World. Poster Presentation at American Thoracic Society (ATS) International Conference, 2023 19-24 May.
8. AstraZeneca. AstraZeneca progresses Ambition Zero Carbon programme with Honeywell partnership to develop next-generation respiratory inhalers. [Online]. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-progresses-ambition-zero-carbon-programme-with-honeywell-partnership-to-develop-next-generation-respiratory-inhalers.html. [Accessed September 2024.]
9. Wilkinson AJK, Maslova E, Janson C, et al., Greenhouse gas emissions associated with suboptimal asthma care in the UK: the SABINA healthCARe-Based envirONmental cost of treatment (CARBON) study. Thorax. 2024 27;79(5):412-421.
10. SMI. Decarbonising patient care pathways. [Online]. Available at: https://a.storyblok.com/f/109506/x/88fe7ea368/smi-hstf-pcp-whitepaper.pdf. [Accessed September 2024.]
11. Usmani OS, Levy ML. Effective respiratory management of asthma and COPD and the environmental impacts of inhalers. NPJ Prim Care Respir Med. 2023;33(1):24.