EMA has recommended a change in the composition of Trixeo Aerosphere and its duplicate product Riltrava Aerosphere to replace the existing gas propellant with a low global warming potential (GWP) gas alternative. The new low GWP alternative propellant has a 1000-fold reduction in global warming potential and similar physical properties compared to the current propellant.
Trixeo Aerosphere and Riltrava Aerosphere are the first inhaled medicines in the EU that have a gas propellant with low GWP. They are used for maintenance treatment in a subset of adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) and are administered as two inhalations twice daily using a metered dose inhaler (MDI).
A critical component of the formulation of an MDI is the propellant (liquified compressed gas) that generates an aerosol cloud containing the small particles of active pharmaceutical ingredients that are then inhaled by the patient.
High GWP gases, including hydrofluorocarbon gases such as the propellants used in pressurised MDIs treating respiratory diseases, are being phased out for environmental reasons in line with the current EU Regulation on fluorinated greenhouse gases (EU Regulation 2024/573), and applicable legislation in other regulatory constituencies. The marketing authorisation holder for Trixeo/Riltrava Aerosphere investigated replacement options for the current propellant, with a focus on a lower GWP propellant that could maintain the same performance properties for the medicinal product.
The reformulated Trixeo/Riltrava Aerosphere with the same active ingredients and dose has been characterised in line with the principles outlined in the draft Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products for asthma and COPD and is therapeutically equivalent (i.e. works the same way and gives the same results in the lungs and the body) to the product currently on the market.
Studies have confirmed that the safety and efficacy of the reformulated medicine are equivalent to those of the currently approved product.
The opinion will now be sent to the European Commission for the adoption of a decision on the variation to the marketing authorisation.
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