UK approves AZ inhaler with 'greener' propellant

AstraZeneca has claimed UK approval for a new version of its respiratory triple therapy Trixeo Aerosphere that contains a propellant with a massively reduced global warming potential (GWP).

The drug – known as Breztri in some markets including the US, China, and Japan – is the first of AZ's respiratory medicines to transition to the new propellant, which has 99.9% lower GWP than propellants used in currently available pressurised metered-dose inhaler (pMDIs).

AZ has been working on a project to develop medicines using the propellant – called HFO-1234ze – with industrial conglomerate Honeywell since 2020, and the UK is the first country to approve a product based on the technology.

Trixeo has been approved in the UK for several years as a treatment for chronic obstructive pulmonary disease (COPD), and the new version is scheduled to launch in the second half of this year. The drug is also set to be filed shortly as an asthma treatment.

The Medicines and Healthcare Products Regulatory Agency (MHRA) approved Trixeo (budesonide/glycopyrronium/formoterol fumarate) based on data showing that the new formulation was bioequivalent to the original medicine, which uses an older propellant known as HFA-134a.

AZ has said it intends to transition all of its pMDIs to the new propellant by 2030, and noted that the new Trixeo/Breztri inhaler is also under regulatory review in Europe, China, and other countries.

pMDIs started to be transitioned from ozone-depleting chlorofluorocarbon (CFC) to hydrofluoroalkane propellants in the early 2000s to try to improve their environmental profile, but HFAs remain powerful greenhouse gases (GHGs) that can contribute to global warming. HFO-1234ze(E) is described as a fluorinated gas with "near-zero" GWP.

Tom Keith-Roach, president of AZ's UK business, said: "The UK approval of Trixeo Aerosphere with the [new] 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."

AZ has said it is currently on course to reduce its GHG emissions by 98% by 2026 en route to a 90% absolute emissions reduction by 2045. It also intends to become carbon negative for residual emissions by 2030, backed up by initiatives such as the planting of 200 million trees across six continents by the end of the decade.

"With 1.2 million people using inhalers in the UK, there is no doubt about the impact they have on the environment," said Karin Smyth, Minister of State for Health. "Through our Plan for Change, we will lower our carbon footprint in our mission towards Net Zero and rebuild our NHS," she added.

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