EMA Supports AstraZeneca’s Eco-Friendly Trixeo Aerosphere for COPD with Ultra-Low Emission Propellant

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EMA Supports AstraZeneca’s Eco-Friendly Trixeo Aerosphere for COPD with Ultra-Low Emission Propellant

(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler (pMDI) in AstraZeneca’s portfolio to make this transition, combining effective COPD treatment with environmental responsibility. Clinical trials confirmed the new formulation maintains efficacy and safety while helping advance AstraZeneca’s Ambition Zero Carbon strategy. Regulatory transition in Europe will begin in the coming months, with ongoing reviews underway globally.

(PRESS RELEASE) CAMBRIDGE, 25-Jul-2025 — /EuropaWire/ — AstraZeneca has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to update the label for Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate) for adult patients with chronic obstructive pulmonary disease (COPD) in the European Union. This update marks the first approval of a pressurised metered-dose inhaler (pMDI) using a next-generation propellant with 99.9% lower Global Warming Potential (GWP) than current alternatives.

As the first medicine in AstraZeneca’s portfolio to adopt this climate-conscious formulation, Trixeo offers the same triple-combination therapy in a pMDI with a carbon footprint comparable to non-propellant-based inhalers. The transition follows a clinical development programme demonstrating bioequivalence between Trixeo with the next-generation propellant and its existing formulation, with no changes in efficacy, safety or tolerability profiles.

Professor Frederik Trinkmann of Heidelberg University Hospital emphasised the clinical and environmental significance of the shift: “Millions of Europeans, especially vulnerable groups like children and the elderly, rely on pMDIs. Trixeo’s transition ensures patients receive effective care while reducing environmental impact.”

The updated formulation was first approved in the UK in May 2025 and is currently under regulatory review in several other countries, including China. The CHMP decision allows AstraZeneca to begin the transition of Trixeo to the next-generation propellant across the EU in the coming months.

Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, commented, “This milestone reflects our dual commitment to patient care and environmental sustainability. It is the first step in our broader plan to transition our entire pMDI portfolio to near-zero GWP propellants by 2030 under our Ambition Zero Carbon strategy.”

Trixeo, known as Breztri Aerosphere in the US, China and Japan, is approved for COPD treatment in over 80 countries and has been prescribed to more than five million patients worldwide. It combines a long-acting β2-agonist (formoterol fumarate), a long-acting muscarinic antagonist (glycopyrronium bromide), and an inhaled corticosteroid (budesonide) in a single pMDI.

The next-generation propellant, developed through a collaboration with Honeywell, plays a vital role in AstraZeneca’s decarbonisation efforts. Though pMDIs contribute only 0.04% of global greenhouse gas emissions, studies show that uncontrolled respiratory symptoms result in significantly higher environmental burdens due to increased healthcare resource utilisation.

Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients’ Associations, added: “COPD is the third leading cause of death globally. We welcome this innovation that meets patient needs while supporting a healthier planet.”

With further clinical studies underway for other pMDI treatments, AstraZeneca is poised to lead the transformation of respiratory care into a more environmentally sustainable model without compromising patient outcomes.

Notes

AstraZeneca’s next-generation propellant clinical development programme
The clinical development programme has been initiated to assess the efficacy and safety of the next-generation, near-zero Global Warming Potential propellant with the AstraZeneca portfolio of inhaled medicines delivered by pressurised metered-dose inhalers (pMDIs).

The first medicine to be assessed in the programme was  Breztri/Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.12-17 The programme established bioequivalence between Breztri/Trixeo with the next-generation propellant and  Breztri/Trixeo with the current propellant.4,5 The safety and tolerability profile for Breztri/Trixeo with the next-generation propellant was consistent with the known profile of the medicine.

Additional studies are underway to assess the bioequivalence of the next-generation propellant to the current propellant with AstraZeneca’s other medicines delivered by pMDIs.

Breztri/Trixeo Aerosphere
Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under the brand name Trixeo Aerosphere in the EU and UK and Breztri Aerosphere in Japan, China and the US, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS), and delivered via the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat COPD in more than 80 countries worldwide including the US, EU, China, Japan, and has been prescribed to more than five million patients globally.

Breztri/Trixeo Aerosphere with the next-generation propellant will maintain the same indication, product strength and dosage regimen as Breztri/Trixeo Aerosphere with the current propellant.

AstraZeneca’s Collaboration with Honeywell
Developed by Honeywell, the medical grade version of the next-generation propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Honeywell to develop respiratory inhaled medicines using the new propellant.

Ambition Zero Carbon
Through its Ambition Zero Carbon strategy, AstraZeneca is pursuing bold, science-based decarbonisation targets, accelerating progress towards net zero. 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
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 and follow the Company on social media @AstraZeneca.

Contacts
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References

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SOURCE: AstraZeneca

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