Corrects paragraph 8 to say propellant offers 99.9% lower global warming potential, not "up to 99.9%", after company clarification
July 25 (Reuters) - A panel of the European medicines regulator has recommended approving an eco-friendly version of AstraZeneca's AZN.L inhaler for the treatment of a chronic lung condition, the drugmaker said on Friday.
The European Medicines Agency's Committee for Medicinal Products for Human Use has backed the use of a new type of a pressurised gas in the company's triple-drug inhaler Trixeo Aerosphere.
In this version, Trixeo Aerosphere, also called Breztri Aerosphere in some regions, will use a next-generation, medical-grade propellant from Honeywell HON.O to deliver metered-doses to patients' lungs as part of AstraZeneca's green push.
The inhaler, with an older propellant, is already approved in Europe for the treatment of adults with chronic obstructive pulmonary disease, commonly referred to "smoker's lung" as the disease typically affects cigarette smokers. But it can also be caused by air pollution and related occupational hazards.
Trixeo Aerosphere's eco-friendly version was approved by British regulators in May, marking the world's first, and is currently under review in other countries, including China.
CHMP's recommendation for European Union's approval is based on the results from trials, which showed the latest propellant was comparable to the current one in delivering doses, without any new safety risks.
"CHMP's positive opinion of Trixeo Aerosphere with the next-generation propellant allows us to address the needs of both patients and the planet," AstraZeneca executive Ruud Dobber said.
Honeywell's new propellant offers 99.9% lower global warming potential compared to those currently used, leaving a lower carbon footprint, AstraZeneca said.
If formally approved by the European Commission, which has the final authority, Trixeo Aerosphere would be the first in the EU to use the new delivery mechanism. The EC typically follows the advise of the EMA, but is not bound to do so.
The inhaler made $978 million in revenue for AstraZeneca in 2024. Rival therapies for COPD include Sanofi-Regeneron's SASY.PA, REGN.O Dupixent, GSK's GSK.L Trelegy Ellipta and Verona Pharma's I9SAy.F Ohtuvayre.
AstraZeneca said it would now begin to transition its Trixeo supply to the new propellant in Europe, based on CHMP's backing.
(Reporting by Pushkala Aripaka and Unnamalai L in Bengaluru; Editing by Shilpi Majumdar)
((Unnamalai.L@thomsonreuters.com))
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