UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced this week that it has received marketing approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its fixed-dose triple-combination therapy Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF). This marks the first approval for a medicine utilizing the next-generation propellant, HFO-1234ze(E), and is indicated for the treatment of chronic obstructive pulmonary disease (COPD) in adults.
Trixeo Aerosphere Overview
Trixeo Aerosphere, which is marketed as Breztri Aerosphere in the US, China, and Japan, gained approval based on results from the next-generation propellant clinical development program. The clinical data demonstrated bioequivalence between Trixeo with the new propellant HFO-1234ze(E) and the current formulation using HFA-134a. The safety and tolerability profiles were consistent with the known characteristics of the medication.-Fineline Info & Tech
