AstraZeneca Completes Clinical Program for Low Global Warming Potential Inhaler
Key Insights
AstraZeneca has completed clinical studies for Breztri/Trixeo Aerosphere (search), transitioning to a next-generation propellant with 99.9% lower Global Warming Potential.
Regulatory submissions in Europe, the UK, and China are expected before the end of 2024, marking a significant step in reducing the carbon footprint of pMDIs.
The new propellant, HFO-1234ze, developed in collaboration with Honeywell (search), supports AstraZeneca's Ambition Zero Carbon strategy for emissions reduction.
AstraZeneca has concluded its clinical program supporting the transition of Breztri/Trixeo Aerosphere (search) (budesonide/glycopyrronium/formoterol fumarate) to a next-generation propellant boasting a 99.9% reduction in Global Warming Potential (GWP) compared to current pMDI propellants. This advancement marks a significant stride in reducing the environmental impact of inhaled respiratory medicines while maintaining patient access to essential treatments.
Transition to Next-Generation Propellant
Breztri, a triple-combination therapy for chronic obstructive pulmonary disease (COPD (search)), will be the first AstraZeneca pMDI to transition to the new propellant. Clinical programs are underway to extend this transition across AstraZeneca's broader pMDI portfolio. While pMDIs contribute less than 0.04% of global greenhouse gas emissions, AstraZeneca aims to substantially reduce this burden through this initiative.
Expert Commentary
Professor Omar Usmani, Respiratory Medicine at Imperial College London, emphasized the importance of this transition: "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."
Regulatory Submissions and Clinical Data
Results from the Breztri studies utilizing the next-generation propellant will be submitted to regulatory authorities, with initial submissions anticipated in Europe, the UK, and China before the close of 2024. The propellant, a medical-grade version of HFO-1234ze developed by Honeywell (search), has demonstrated systemic and lung bioequivalence in Phase I studies presented at the American Thoracic Society (ATS) 2024 Conference. Phase IIIb data presented at the European Respiratory Society (ERS) Congress 2024, further supports its efficacy.
Impact on Respiratory Care and Sustainability
Chronic respiratory diseases, including COPD (search), affect hundreds of millions globally. Respiratory inhaled medicines delivered via pMDIs account for 78% of inhaler usage worldwide. Reducing the carbon impact of pMDIs is a key element of AstraZeneca’s Ambition Zero Carbon strategy. This strategy includes targets to reduce its entire value chain carbon footprint by 50% by 2030, and achieve a 90% absolute emissions reduction (from a 2019 baseline) by 2045.
Breztri Aerosphere Overview
Breztri/Trixeo Aerosphere (search) (budesonide/glycopyrronium/formoterol fumarate) is a single-inhaler, fixed-dose triple combination therapy containing formoterol fumarate (a LABA), glycopyrronium bromide (a LAMA), and budesonide (an ICS), delivered via the Aerosphere pMDI. It is approved for COPD (search) treatment in over 50 countries, including the US, EU, China, and Japan, and is currently in Phase III trials for asthma (search).