12th May 2025 09:09
(Alliance News) - AstraZeneca PLC on Monday announced that its medicine Trixeo Aerosphere has been approved by the UK Medicines & Healthcare Products Regulatory Agency with "an innovative, next-generation propellant with near-zero global warming potential".
The Cambridge, England-based pharmaceutical company noted that Trixeo Aerosphere, also known as budesonide/glycopyrronium/formoterol fumarate or BGF and marketed as Breztri Aerosphere in the US, China and Japan, is already licensed as a treatment for adults with chronic obstructive pulmonary disease.
"This is the first medicine delivered by a pressurised metered-dose inhaler (pMDI) approved with the propellant that has 99.9% lower GWP than propellants used in currently available pMDIs," Astra explained, saying that Trixeo with the new propellant will have a lower carbon footprint comparable to inhaled medications without a propellant.
Trixeo is the first medication in Astra's pMDI portfolio to switch to using the new propellant, expecting to initiate the transition "in the coming months", and the company intends to adopt it across the wider portfolio by 2030.
AstraZeneca said the UK MHRA's approval was based on results from the next-generation propellant clinical development programme. These "which demonstrated bioequivalence between Trixeo with the next-generation propellant, HFO-1234ze(E), and Trixeo with the current propellant, HFA-134a".
It said regulatory applications for Trixeo/Breztri with the next-generation propellant are currently under review in Europe, China and other regions.
"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," commented Ruud Dobber, executive vice president of Astra's BioPharmaceuticals Business Unit. "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."
Shares in AstraZeneca were trading 3.8% lower at 9,850.00 pence in London on Monday morning.
By Emma Curzon, Alliance News reporter
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