As with all medicines, the MHRA will continue to monitor the
safety and effectiveness of Trixeo Aerosphere.
The Medicines and Healthcare products Regulatory Agency (MHRA)
has approved a low-carbon version of Trixeo Aerosphere, a triple
combination inhaler for adults with moderate to severe chronic
obstructive pulmonary disease (COPD), which uses the propellant,
HFO-1234ze(E), and is just as safe and effective as the previous
version.
COPD affects around 1.2 million people in the UK and is the
second most common cause of emergency hospital admissions. Trixeo
Aerosphere is used to make breathing easier and improve symptoms
of COPD such as shortness of breath, wheezing and cough. It can
also prevent flare-ups (exacerbations) of COPD.
The newly approved version of Trixeo Aerosphere replaces the
propellant HFA-134a with HFO-1234ze(E) – a fluorinated gas with
near-zero global warming potential. The propellant itself is not
an active medicine but is used to deliver the inhaled dose.
This new version will be available in the UK from the second half
of 2025. In the meantime, the current version of Trixeo
Aerosphere will continue to be available to patients.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality,
safe and effective medicines are key priorities for us.
Inhalers are a cornerstone of COPD treatment, helping manage
symptoms and prevent exacerbations. However, some inhalers can
also contribute to greenhouse gas emissions through their
propellants.
This approval supports the continued availability of a widely
used COPD treatment while enabling a transition to inhalers with
a lower carbon footprint – without compromising on safety,
quality or clinical benefit.
, Minister of State for Health,
said:
With 1.2 million people using inhalers in the UK, there is no
doubt about the impact they have on the environment.
This is another example of the UK being at the forefront of
delivering innovative, environmentally friendly and top-quality
medicines that will benefit patients across the UK.
Through our Plan for Change, we will lower our carbon footprint
in our mission towards Net Zero and rebuild our NHS.
Trixeo Aerosphere is used twice daily (two puffs in the morning
and evening) as a long-term maintenance treatment. No changes
have been made to the active ingredients, recommended dose or
clinical use.
The MHRA's approval is supported by clinical evidence showing
that the new propellant, HFO-1234ze(E), delivers the same dose
and therapeutic effect as the original formulation. The
assessment included evidence on product quality, device
performance and stability.
A full list of side effects for the current version of the
product can be found in the Patient Information Leaflet (PIL) or
the Summary of Product Characteristics (SmPC), which will be
updated when the new version of the medicine becomes available.
As with all medicines, the MHRA will continue to monitor the
safety and effectiveness of Trixeo Aerosphere. Anyone
experiencing suspected side effects is encouraged to report them
through the Yellow Card scheme at yellowcard.mhra.gov.uk or
via the Yellow Card app.
Notes to editors
- The variation to the existing marketing authorisation of
Trixeo Aerosphere was granted on 9 May 2025 to AstraZeneca.
- The Summary of Product Characteristics and Patient
Information Leaflet for the current version of the product can be
found here.
An updated SmPC and PIL will be available once the new version
of the medicine is available.
- For more information about COPD, visit: https://www.nhs.uk/conditions/chronic-obstructive-pulmonary-disease-copd/
