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…