Trixeo Aerosphere® receives positive EU CHMP opinion as first inhaled medicine using next-generation propellant with near-zero Global Warming Potential

PRESS RELEASE

​Aerosphere®(budesonide/glycopyrronium/formoterol fumarate or BGF), already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, endorsing it for use in the European Union (EU) with an innovative, next-generation propellant with near-zero Global Warming Potential (GWP)^1,2

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Approximately 36 million people in Europe are living with COPD and it is the leading cause of death in the EU and the 3th leading cause globally (excluding COVID)^3,4. According to the International Respiratory Coalition, almost 1.3 million Belgians suffer from a respiratory illness, of which almost 600,000 from COPD⁵. This accounts for nearly 6,000 casualties from COPD in Belgium. So the launch of the next-generation propellant marks an important milestone: Belgian patients with a respiratory illness will gain access to a proven triple therapy while the climate footprint of the inhaler is dramatically reduced. Availability in Belgium is expected as of early 2026.

A gamechanger for patients with COPD

Trixeo Aerosphere®, AstraZeneca’s fixed-dosed triple-combination therapy for COPD, is the Company’s first medicine to transition to the next-generation propellant Trixeo is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) using a propellant that offers 99.9% lower GWP than propellants used in currently available pMDIs. This fixed-dose triple-combination therapy, marketed as Breztri Aerosphere® in the US, China and Japan, will now have a low carbon footprint comparable to inhaled medicines that do not require a propellant.³ Based on the CHMP positive opinion, AstraZeneca will now begin to transition its Trixeo supply to the next-generation propellant in Europe.

“COPD remains a major challenge for patients, families and the Belgian healthcare system. The International Respiratory Coalition estimated that almost 1.3 million Belgians suffer from a respiratory illness. With the next-generation propellant, we are offering a treatment that improves outcomes while supporting our shared responsibility to protect the environment. Today, more than 350,000 patients in Belgium are treated with AstraZeneca medicines. We are committed to transforming lives beyond treatment – improving overall well-being and positively impacting the lives of millions of people in our country,” said Angela Thompson, Country President Belgium & Luxembourg, AstraZeneca.”

The CHMP positive opinion is based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the current propellant.^4,5 The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine.

Frederik Trinkmann, Professor and Senior Pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said: “Respiratory medicines delivered by pressurised metered-dose inhalers are essential for millions of people living with respiratory diseases in Europe, including specific vulnerable populations such as children and the elderly. The transition of Trixeo to the propellant with near-zero Global Warming Potential ensures clinicians’ treatment decisions can focus on clinical needs while also supporting environmental goals.” ​

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The CHMP positive opinion of Trixeo Aerosphere® with the next-generation propellant allows us to address the needs of both patients and the planet and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the EU. Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.”

Trixeo with the next-generation propellant received its first approval in the UK in May 2025 with regulatory applications also currently under review in China and additional countries.

Paving the way to Zero Carbon

Trixeo is the first medicine in AstraZeneca’s portfolio of medicines delivered by pMDIs to transition to the new propellant. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy⁶. In the EU, the Company plans to initiate the transition of Trixeo to the next-generation propellant in the coming months.

Chronic respiratory diseases, including COPD, affect hundreds of millions of people around the world⁷. Respiratory inhaled medicines delivered by pMDIs account for 76% of all inhaler use in Europe, and contribute 0.04% of global greenhouse gases^8,9. Studies show that the largest environmental contribution from respiratory diseases comes from patients’ symptoms not being adequately controlled and resulting increased healthcare utilisation^10,11. Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care¹².

“Sustainability is at the heart of everything we do,” added Angela Thompson. “With the next-generation propellant, we are not only delivering better care for COPD patients but also taking tangible climate action in Belgium. It is a textbook example of how access to healthcare, environmental protection and ethics & transparency – the three pillars of our sustainability strategy – go hand in hand.”

Putting Belgium on the map

Belgium has an important role in this story. AstraZeneca Belgium, headquartered in Groot-Bijgaarden (Brussels) with over 300 employees, works closely with healthcare professionals, hospitals, research centres and policymakers. Belgium is also a key hub for clinical research within AstraZeneca’s global network, with numerous trials conducted in partnership with leading academic institutions. These collaborations ensure that Belgian patients benefit from cutting-edge science while contributing to international medical progress. Through this strong local presence, AstraZeneca not only supports over 350,000 Belgian patients each year with its medicines but also contributes to the resilience of the Belgian healthcare system and economy.

With the next-generation propellant, AstraZeneca builds on its long heritage in respiratory medicine. The company remains committed to pioneering solutions that address unmet patient needs, improve adherence, and at the same time reduce the environmental footprint of healthcare.

Media Contact (Belgium):
​Elisabeth De Groof, Corporate Communications Manager
​T +32 (0)498 82 76 28
​elisabeth.degroof@astrazeneca.com

For more information and additional references:

https://www.astrazeneca.com/media-centre/press-releases/2025/trixeo-aerosphere-receives-positive-eu-chmp-opinion-first-inhaled-medicine-using-next-generation-propellant-with-near-zero-global-warming-potential.html

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development and commercialisation of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

In Belgium, AstraZeneca is based in Groot-Bijgaarden (Brussels) and employs over 300 people. The company plays a vital role in addressing the country’s most pressing health challenges, including COPD, asthma, cancer and cardiovascular disease, while actively engaging in clinical research and sustainability initiatives.

For more information: www.astrazeneca.be

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