The European Medicines Agency (EMA) has recommended a change in composition for Trixeo Aerosphere, also known as Riltrava Aerosphere. Both drugs are used for maintenance treatment in a subset of adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).
The recomposition involves replacing the existing gas propellant, HFA-134a, with a low global warming-potential (GWP) gas alternative called HFO-1234ze(E). The propellant is used for drug delivery and is not an active medicine.
AstraZeneca claims that the new propellant will lead to a 99.9% reduction in GWP and an 85% reduction in greenhouse gas emissions compared with current propellants. The company adds that its carbon footprint is similar to that of dry powder inhalers.
The reformulation was approved by British regulators in May and is currently under review in other countries such as China.
COPD is an umbrella term for a group of lung conditions, including emphysema and chronic bronchitis. Symptoms include shortness of breath, frequent chest infections, and persistent wheezing. Estimates suggest that around 36.5 million people had COPD in Europe in 2020, and that this number will increase to 49.5 million by 2050.
Trixeo Aerosphere and Riltrava Aerosphere have three active ingredients: budesonide, glycopyrronium, and formoterol fumarate dihydrate. Budesonide is a glucocorticosteroid that exerts rapid, dose-dependent, anti-inflammatory action on the airways when inhaled. Meanwhile, glycopyrronium is a long-acting muscarinic antagonist and formoterol fumarate dihydrate is a selective beta2-adrenergic agonist. Both result in bronchodilation.
The reformulation comes as the EU phases out high GWP gases for environmental reasons. The EMA reported that studies confirm the safety and efficacy of the reformulated medicine are equivalent to those of the currently approved product. The associated studies will be made available in the variation assessment report following the European Commission’s final decision, which is expected in the coming weeks.
Annie Lennon is a medical journalist. Her writing appears on Medscape, WebMD, and Medical News Today, among other outlets.