AstraZeneca announced the that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the company’s marketing application for a reformulated Trixeo (Breztri) Aerosphere budesonide / glycopyrronium / formoterol fumarate that uses Honeywell’s Solstice Air HFO-1234ze as a propellant. The company says that it expects to launch the HFO-1234ze Trixeo, which represents the first approval of an MDI reformulated with a low global warming potential (LGWP) propellant, in the next few months.
The original formulation of Trixeo that was formulated with HFA 134a was approved in Europe for the treatment of COPD in December 2020. Breztri Aerosphere formulated with HFA 134a is currently marketed for the treatment of COPD in Japan, in China, and in the US.
AstraZeneca announced in February 2022 that it had partnered with Honeywell on reformulation of MDIs with HFO 1234ze and that it had already conducted a Phase 1 trial of Breztri with the new propellant. In September 2024, the company said that it planned submissions for the reformulated MDI in Europe, China, and the UK by the end of that year after completing the necessary studies. According to the new announcement, applications for the reformulated Trixeo / Breztri are under review at this time in Europe, China, and more countries, and it plans to reformulate its other MDIs to HFO-1234ze by 2030.
AstraZeneca Executive VP, BioPharmaceuticals Business Unit, Ruud Dobber commented, “The UK approval of Trixeo Aerosphere with the next generation propellant is an industry first and a major milestone in AstraZeneca’s commitment to transition our pMDI portfolio to the propellant with near-zero global warming potential. Starting with Trixeo, we are addressing the needs of both patients and the environment in devastating diseases like COPD, which affects hundreds of millions of people and is a leading cause of death globally.”
AstraZeneca UK President Tom Keith-Roach said, “The UK approval of Trixeo Aerosphere with the near-zero global warming potential propellant marks a world first and an important step in improving the environmental impact of our portfolio of inhaled respiratory medicines to support the NHS in achieving its net zero carbon goals. Trixeo with our next generation propellant allows us to address the needs of both patients and the planet.”
Read the AstraZeneca press release
