As a young, naive journalist 20 years ago, I asked a pharma company what they were doing to make their processes and medicines better for the environment.
They laughed at me.
The pharma business is about making life-saving medicines. In contrast, being environmentally friendly wasn’t important. Thankfully, the times have changed. Making life-saving medicines remains a critical endeavour. But there’s a growing realization that the health of the planet also deserves attention. Rules and regulations are also forcing companies to take action.
Historically, pharma manufacturers have been reluctant to revisit old medicines to make them or their manufacturing processes more environmentally friendly – because touching an already approved product is risky and expensive. With inhaled medicines, however, there is now regulatory impetus: Regulation (EU) 2024/573 on fluorinated greenhouse gases mandates the use of lower-global warming potential (GWP) alternatives in medicinal products where feasible. From January 2025, labelling requirements for such products will also apply under the same regulation
Now, for the first time in Europe, an existing inhaled medicine has been reformulated to use a gas propellant with low global warming potential.
On July 25, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for a reformulated version of AstraZeneca’s COPD medicine Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate) and its duplicate, Riltrava Aerosphere. The updated formulation replaces the hydrofluoroalkane propellant with a next-generation hydrofluoroolefin (HFO-1234ze(E)).
According to AstraZeneca, the new propellant reduces greenhouse gas emissions by around 99.9% compared with the existing formulation. Clinical and quality data show that the reformulated product is therapeutically equivalent to the original.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit at AstraZeneca, said: “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 pressurised metered-dose inhaled respiratory medicines is an important step towards achieving our Ambition Zero Carbon strategy.”
As the European Commission typically follows the opinions issued by the CHMP, full approval of the reformulation is expected within 67 days. AstraZeneca says it is also looking to transition its wider pressurised metered-dose inhaler portfolio to the new propellant by 2030. The reformulated version is already approved in the UK (approved in May 2025) and is currently under review in additional markets, including China.
The propellant was developed by Honeywell – stemming from a collaboration announced in 2022.
I’m currently working on a special feature on sustainability so I’ve had a lot of conversations these past few weeks about how pharma is adopting ambitious ESG goals – and the actions they are taking in manufacturing plants. If you want to talk to me about your company’s sustainability approach, then get in touch at stephanie.vine@conexiant.com.
Newsletters
Receive the latest pharmaceutical news, personalities, education, and career development – weekly to your inbox.
