World-first approval supports AstraZeneca’s sustainability goals

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval of the low-carbon version of the chronic obstructive pulmonary disorder (COPD) inhaler Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF). AstraZeneca’s fixed-dosed combination therapy contains formoterol fumarate, a long-acting β2 agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA), with budesonide, an inhaled corticosteroid (ICS).

Improving environmental sustainability of inhaled respiratory medicines

Authorised for use in the UK, the treatment is delivered via the Aerosphere pressurised metered-dose inhaler (pMDI). It is the first medicine delivered by a pMDI approved with the propellant that has 99.9 percent lower global warming potential (GWP) compared to propellants used in currently available pMDIs, AstraZeneca explained. 

Trixeo with the next-generation propellant will have a low carbon footprint, comparable to inhaled medicines that do not need a propellant, 2022 research by Hargreaves et al. shows.

In the UK, pMDIs make up 70 percent of all inhaled medicines use with inhaler emissions, according to Asthma and Lung UK.  

Trixeo is the first of AstraZeneca’s pMDIs to transition to the new propellant. The shift aligns with the pharmaceutical company’s Ambition Zero Carbon strategy, where it is targeting a shift for its wider pMDI portfolio to the near-zero GWP propellant by 2030.

What clinical evidence is MHRA’s approval of AstraZeneca Trixeo Aerosphere’s COPD inhaler based on?

The MHRA’s decision is based on findings from the next-generation propellant clinical development programme. Trixeo was shown to be bioequivalent to the next-generation propellant, HFO-1234ze(E), and Trixeo with the current propellant, HFA-134a, based on data presented at American Thoracic Society International Conference 2024. 

“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,” shared Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca.

“We are encouraged to see the whole industry joining our efforts to transition towards more medicines with reduced environmental impact, re-affirming that improving the carbon footprint of these life-saving medicines is critical,” Andrew Menzies-Gow, Vice President Respiratory & Immunology, Global Biopharmaceuticals Medical at AstraZeneca shared with EPR.