AstraZeneca’s Trixeo Aerosphere approved for use in UK with propellant

AstraZeneca’s (AZN) Trixeo Aerosphere, already licensed for the treatment of chronic obstructive pulmonary disease in adults, has now been approved for use in the UK with an innovative, next-generation propellant with near-zero Global Warming Potential. This is the first medicine delivered by a pressurised metered-dose inhaler approved with the propellant that has 99.9% lower GWP than propellants used in currently available pMDIs.2 Trixeo with the next-generation propellant will have a low carbon footprint, comparable to inhaled medicines that do not require a propellant. Trixeo, a fixed-dose triple-combination therapy, is marketed as Breztri Aerosphere in the US, China and Japan. The approval by the UK Medicines and Healthcare Products Regulatory Agency was based on results from the next-generation propellant clinical development programme, which demonstrated bioequivalence between Trixeo with the next-generation propellant, HFO-1234ze(E), and Trixeo with the current propellant, HFA-134a. The safety and tolerability profile for Trixeo with the next-generation propellant was consistent with the known profile of the medicine.