AstraZeneca announced that it now has the data to support regulatory submissions for a new formulation of of Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol using Honeywell’s Solstice Air HFO 1234ze(e), a low global warming potential (LGWP) propellant. The company says that it now plans to initiate submissions for the reformulated MDI by the end of this year in Europe, China, and the UK.
In June 2019, the triple combination inhaler was approved in Japan for the treatment of COPD, followed by approval in China in December 2019. Breztri Aerosphere has been approved in the US since July 2020; in Europe, Trixeo Aerosphere was approved in December 2020. The MDI is now approved in more that 50 countries.
AstraZeneca announced a partnership with Honeywell to develop new formulations transitioning the company’s MDI’s to HFO 1234ze in February 2022 and said at the time that a Phase 1 trial of a reformulated Breztri had already been conducted. According to the company, clinical studies of LGWP formulations of other MDIs are currently underway.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Sharon Barr commented, “Essential, life-saving medicines delivered to patients by pressurized metered dose inhalers are the most used treatments in respiratory care and ensuring access to them based on clinical need is critical to optimizing patient outcomes. We have now completed the studies that support the first regulatory filings to transition Breztri to the innovative propellant with near-zero global warming potential as part of our commitment to patients and the planet.”
Read the AstraZeneca press release.
