AstraZeneca has finalized the studies supporting the regulatory filings for Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) to transition to a new, next-generation propellant. This propellant has a 99.9% lower Global Warming Potential compared to those used in current inhaled medications.
Breztri, a triple-combination therapy for chronic obstructive pulmonary disease (COPD), will be the first in AstraZeneca’s line of pressurized metered-dose inhalers (pMDIs) to use this advanced propellant. The company is also advancing clinical programs to update its broader pMDI portfolio to this new propellant. Although pMDIs account for less than 0.04% of global greenhouse gas emissions, AstraZeneca aims to significantly reduce this impact.
Omar Usmani, Professor of Respiratory Medicine at Imperial College London and a lead investigator on the study, commented, “Pressurized metered-dose inhalers are vital for millions with respiratory conditions worldwide, including vulnerable groups such as children and the elderly. Adopting a propellant with a minimal carbon footprint, comparable to non-propellant-based inhalers, is crucial for both planetary health and achieving optimal patient outcomes.”
Sharon Barr, Ph.D., Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, added, “Pressurized metered-dose inhalers are crucial for respiratory care, and ensuring their accessibility based on clinical need is key to improving patient outcomes. We’ve completed the studies for transitioning Breztri to the innovative propellant with near-zero Global Warming Potential, reinforcing our dedication to both patients and environmental sustainability.”
Results from these studies will be submitted to regulatory authorities, with initial filings in Europe, the UK, and China expected before the end of 2024.
AstraZeneca is exploring the medical-grade version of HFO-1234ze, a next-generation propellant, for its pMDI medicines. Phase I studies on systemic and lung bioequivalence were presented at the American Thoracic Society (ATS) 2024 Conference in May, and Phase IIIb bronchospasm study results will be discussed at the European Respiratory Society (ERS) Congress 2024. Additional data will be shared at upcoming medical meetings.
Chronic respiratory diseases, including COPD and asthma, impact hundreds of millions globally. Inhaled medicines via pMDIs represent 78% of inhaler usage worldwide. Reducing the carbon footprint of pMDIs is a key aspect of AstraZeneca’s Ambition Zero Carbon strategy, complementing their commitment to enhancing patient outcomes. Evidence-based guidelines can help lower exacerbations and hospitalizations, potentially reducing the overall carbon footprint associated with respiratory care.
