According to AstraZeneca, the EMA’s the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company’s LGWP version of Trixeo (Breztri) Aerosphere budesonide / glycopyrronium / formoterol MDI, which uses Honeywell’s Solstice Air HFO-1234ze as a propellant. The HFO-1234ze Trixeo Aerosphere was also recently approved in the UK.
Trixeo, which was originally formulated with HFA 134a, was approved in Europe for the treatment of COPD in December 2020. AstraZeneca says that it “plans to initiate the transition of Trixeo to the next-generation propellant in the coming months” in the EU and that applications for LGWP Breztri are under review in China, and other countries. The company also said that it expects to convert all of its other MDIs to HFO-1234ze by 2030.
In February 2022, AstraZeneca announced a partnership with Honeywell for reformulation of its MDIs with HFO 1234ze. The company discussed the planned submissions for the reformulated MDI in Europe, China, and the UK in September 2024.
AstraZeneca Executive VP, BioPharmaceuticals Business Unit, Ruud Dobber commented,“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. 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.”
Read the AstraZeneca press release
