AstraZeneca has completed all clinical studies required to support the first filings for the transition of its chronic obstructive pulmonary disease (COPD) inhaler, Breztri to a next-generation propellant (NGP) with near-zero global warming potential.
Results from the clinical studies, which have been presented at conferences this year, will be shared with regulatory authorities, and first submissions in Europe, the UK and China are expected before the end of 2024, the company shared.
Inhalers, specifically those using pressurised metered-dose inhalers (pMDIs), have a significant carbon footprint due to the use of hydrofluoroalkane (HFA) propellants, which are potent greenhouse gases. While inhalers don’t contribute much to global greenhouse gas emissions (less than 0.04%), AstraZeneca has an ambitious target of becoming carbon negative for all residual emissions by 2030.
To address this, new eco-friendly propellants, such as hydrofluoroolefin (HFO) are being developed. Breztri will be the first inhaler in AstraZeneca’s portfolio to use this new, eco-friendly propellant. Named HFO-1234ze, it has 99.9% less impact on global warming compared to the chemicals currently used in inhalers.
Breztri is a medication used to treat COPD. It is a fixed-dose combination of a corticosteroid (budesonide), a long-acting muscarinic antagonist (glycopyrronium) and a long-acting beta2-adrenergic agonist (formoterol fumarate), which is delivered through a pressurised metered dose inhaler. Marketed as Trixeo Aerosphere in the EU, it is approved to treat COPD in more than 50 countries.
One Phase I study (NCT06340581), presented at the American Thoracic Society (ATS) 2024 Conference in May, demonstrated that the new eco-friendly HFO propellant performs the same as the current HFA propellant inhaler, both using a spacer, while also evaluating the performance of the new inhaler without a spacer.
Breztri generated $677m in global sales in 2023, as per AstraZeneca’s financials. According to GlobalData analysis, Breztri sales are expected to rise in the coming years, with the therapy predicted to generate $2.14bn in global sales by 2030.
GlobalData is the parent company of Clinical Trials Arena.
Sharon Barr, executive vice president of biopharmaceuticals R&D at 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.”
