AstraZeneca has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Trixeo Aerosphere using a next-generation propellant with near-zero Global Warming Potential (GWP). The decision supports the company’s plans to reduce the carbon footprint of its respiratory medicines while maintaining treatment for patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate), already approved for the treatment of adults with COPD, has received a positive CHMP opinion for use in the European Union (EU) with a next-generation propellant that has near-zero GWP.
The propellant delivers a 99.9 per cent reduction in GWP compared with those used in current pressurised metered-dose inhalers (pMDIs). As a result, Trixeo will have a carbon footprint comparable to inhaled medicines that do not require a propellant.
Following the positive opinion, AstraZeneca plans to begin transitioning its European Trixeo supply to the new propellant.
The CHMP recommendation is based on AstraZeneca’s next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo using the new propellant and the current formulation.
The safety and tolerability profile of Trixeo with the next-generation propellant was consistent with the medicine’s known profile.
“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,” said Professor Frederik Trinkmann, Senior Pulmonologist at the Thoracic Clinic, Heidelberg University Hospital, Germany.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, added: “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 is the first medicine in AstraZeneca’s portfolio of pMDIs to transition to the new propellant. The company plans to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of its Ambition Zero Carbon strategy.
Trixeo with the new propellant received its first approval in the UK in May 2025. Regulatory applications are also under review in China and additional countries.
According to AstraZeneca, pMDIs account for 76 per cent of inhaler use in Europe and contribute 0.04 per cent of global greenhouse gas emissions.
Studies show the largest environmental impact associated with respiratory diseases comes from poorly controlled symptoms that lead to increased healthcare utilisation. It said implementing evidence-based clinical guidelines can reduce exacerbations and unscheduled healthcare use, improving patient outcomes while also lowering the overall carbon footprint of respiratory care.
Susanna Palkonen, Director of the European Federation of Allergy and Airways Diseases Patients’ Associations, said: “COPD is a devastating disease and the third leading cause of mortality in the world. People living with COPD need access to a treatment which is right for them as well as a healthy environment and clean air. We welcome the positive opinion from the CHMP for the inhaled respiratory medicine containing the next-generation propellant with a significantly reduced carbon footprint.”
Additional studies are underway to assess the next-generation propellant across its wider portfolio of pressurised metered-dose inhalers as it continues its transition to lower-carbon respiratory medicines.
