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The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.
The European Medicines Agency (EMA) announced on July 25, 2025 that its Committee for Medicinal Products for Human Use (CHMP) has approved a change in the existing gas propellant used in budesonide/glycopyrronium/formoterol fumarate (BGF, Trixeo Aerosphere and Riltrava Aerosphere) (1,2). The propellant may be replaced with a low global warming potential (GWP) gas alternative that has a 1000-fold reduction in GWP, 99.9% lower than currently used. BGF will be the first inhaled drug in the European Union to use the new low GWP propellant, according to EMA.
BGF is used as a fixed-dose triple-combination maintenance therapy for adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). The usual dose is two inhalations twice daily using a pressurized metered-dose inhaler (pMDI). The propellant used in pMDIs is a liquified compressed gas that generates an aerosol cloud to deliver the API to the patient through inhalation. These propellants that are typically high GWP, such as hydrofluorocarbon gases, are being phased out to comply with the EU regulation regarding fluorinated greenhouse gases (EU Regulation 2024/573) (3).
AstraZeneca AB, the drug’s marketing authorization holder, focused on a lower GWP propellant for the reformulation, which uses the same API and dose characterized in guideline requirements (4). CHMP’s positive opinion was based on results from the next-generation propellant clinical development program, according to AstraZeneca (2). The new formulation of BGF was found to be therapeutically equivalent to the current product, according to EMA (1). The company plans to transition more of its pMDI portfolio to the new propellant by 2030.
“Respiratory medicines delivered by pressurized 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,” Frederik Trinkmann, professor and senior pulmonologist at the Thoracic Clinic at Heidelberg University Hospital, Germany, said in the press release (2). “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.”
“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,” Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca, said in the release. “Starting with Trixeo, the transition to the near-zero Global Warming Potential propellant across our pressurized metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.”
Susanna Palkonen, director of the European Federation of Allergy and Airways Diseases Patients' Associations, added, “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.”
