AstraZeneca receives positive opinion from EMA for COPD therapy

(Alliance News) - AstraZeneca PLC on Friday said its therapy for the treatment of chronic obstructive pulmonary disease in adults has received a positive opinion from the European Medicines Agency.

The Cambridge, England-based pharmaceutical company said the positive opinion from the Committee for Medicinal Products for Human Use endorses Trixeo Aerosphere, or budesonide/glycopyrronium/formoterol fumarate, for use in the EU with a next-generation propellant with near-zero global warming potential.

Trixeo is the first medicine to be delivered by a pressurised metered-dose inhaler, which uses a propellant that offers 99.9% lower global warming potential than other propellants currently used in other similar inhalers.

The positive opinion from the EMA committee is based on results from a clinical development programme that demonstrated bioequivalence between Trixeo with the next-generation propellant and Trixeo with the currently-used propellant.

"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," said Ruud Dobber, executive vice president at AstraZeneca's BioPharmaceuticals business unit.

"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."

Chronic respiratory diseases such as COPD affect hundreds of millions of people globally, AstraZeneca added, with respiratory inhaled medicines delivered by pressurised metered-dose inhalers accounting for 76% of all inhaler use in Europe. The inhalers contribute 0.04% of all global greenhouse gases.

"Studies show that the largest environmental contribution from respiratory diseases comes from patients' symptoms not being adequately controlled and resulting increased healthcare utilisation," the company explained. "Implementing evidence-based guidelines into clinical practice can reduce exacerbations and unscheduled healthcare utilisation, and the resulting improved patient outcomes may also decrease the overall carbon footprint associated with respiratory care."

Shares in AstraZeneca were down 0.4% at 10,858.00 pence in London on Friday at midday. The stock is down 10% over the past year.

By Emily Parsons, Alliance News reporter

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