AstraZeneca has received the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approval for Trixeo Aerosphere to treat chronic obstructive pulmonary disease (COPD).
Trixeo Aerosphere is a fixed-dose triple-combination inhaler medication that combines budesonide, glycopyrronium, and formoterol fumarate.
The inhaler therapy is approved for use with an advanced new propellant, HFO-1234ze(E), featuring near-zero Global Warming Potential (GWP).
AstraZeneca developed the new propellant in collaboration with Honeywell, which plays a key role in reducing the climate impact of pMDI medicines.
Trixeo Aerosphere is the first pressurised metered-dose inhaler (pMDI) to be approved with a propellant that reduces GWP by 99.9% compared to existing pMDIs, said the company.
AstraZeneca biopharmaceuticals business unit executive vice president Ruud Dobber said: “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.”
The MHRA approval is based on clinical trials showing bioequivalence between Trixeo with the new propellant, HFO-1234ze(E), and the existing propellant, HFA-134a.
The safety and tolerability of Trixeo with the new propellant are in line with the established profile of the medicine.
AstraZeneca plans to transition its entire pMDI portfolio to the near-zero GWP propellant by 2030, aligning with its Ambition Zero Carbon strategy.
The UK will see the transition of Trixeo to the new propellant in the coming months.
Trixeo Aerosphere, marketed as Breztri Aerosphere in China, Japan, and the US, is approved in over 80 countries for COPD and is used by over five million patients globally.
Furthermore, regulatory reviews for Trixeo/Breztri with the next-generation propellant are ongoing in Europe, China, and other countries.
AstraZeneca UK president Tom Keith-Roach said: “The UK approval of Trixeo Aerosphere with the near-zero Global Warming Potential 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.
“Trixeo with our next-generation propellant allows us to address the needs of both patients and the planet.”
