MHRA Approves AstraZeneca's Trixeo Aerosphere for COPD

AstraZeneca has achieved a significant milestone in its environmental strategy with the UK authorization of Trixeo Aerosphere, a groundbreaking inhaler for chronic obstructive pulmonary disease (COPD). This inhaler uses a propellant with an exceptionally low Global Warming Potential (GWP), marking the first instance of a pressurised metered-dose inhaler (pMDI) utilizing this eco-friendly technology. The approval reflects AstraZeneca's commitment to reducing the environmental impact of its products while maintaining effective treatments for patients.

The decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) is based on findings from a clinical development program. This program demonstrated bioequivalence between Trixeo using the new propellant, HFO-1234ze(E), and the traditional propellant, HFA-134a. The tolerability and safety of Trixeo were consistent with its established profile, reinforcing confidence in the transition to the new propellant. Known as Breztri Aerosphere in the US, China, and Japan, Trixeo Aerosphere is a fixed-dose combination therapy for COPD that integrates three significant components: a long-acting β2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (ICS), all delivered via the Aerosphere pMDI.

AstraZeneca's ambition to evolve its pMDI portfolio to propellants with near-zero GWP by 2030 is part of its broader Ambition Zero Carbon strategy. This approach aims to substantially cut greenhouse gas emissions from its operations, aligning with global sustainability goals. The transition of Trixeo Aerosphere in the UK is scheduled to commence shortly, with regulatory applications for the next-generation propellant under review in various regions, including China and Europe. This initiative underscores AstraZeneca's dedication to developing treatments that cater to patient needs while addressing environmental concerns.

Ruud Dobber, AstraZeneca's executive vice-president of the biopharmaceuticals business unit, emphasized the significance of the UK approval. He highlighted it as a pioneering step in the pharmaceutical industry's move towards eco-friendly inhalation therapies. Dobber noted that COPD is a severe disease affecting millions worldwide, and transitioning to a low-GWP propellant in Trixeo Aerosphere reflects AstraZeneca's commitment to both patient care and environmental stewardship.

The development of the medical-grade HFO-1234ze(E) propellant by Honeywell is crucial for reducing the climatic footprint of pMDI medicines. AstraZeneca's partnership with Honeywell, announced in 2022, aims to innovate respiratory inhaled medications using this advanced propellant. This collaboration is a part of AstraZeneca's strategic efforts to achieve net-zero emissions, targeting a dramatic reduction in greenhouse gas emissions from its operations by 2026, compared to 2015 levels.

Through initiatives like these, AstraZeneca is setting a benchmark in the pharmaceutical sector, demonstrating that effective healthcare solutions can go hand in hand with environmental responsibility. The transition to using propellants with minimal GWP represents a forward-thinking approach in addressing global health concerns while contributing to the fight against climate change. As AstraZeneca continues to review and implement these changes worldwide, it reinforces its role as a leader in sustainable healthcare innovation, striving to make significant contributions to reducing the industry's environmental impact while providing essential treatments for life-altering conditions like COPD.