Chiesi has announced the acceptance of regulatory submissions for two LGWP versions of its metered dose inhalers that have been reformulated with Orbia‘s HFA 152a propellant. In the UK, the MHRA recently approved Chiesi’s HFA 152a Clenil Modulite beclometasone MDI for the treatment of asthma. In the US, Chiesi announced in October 2025 that the FDA had accepted its NDA for an HFA 152a formulation of Trimbow beclomethasone dipropionate / formoterol fumarate / glycopyrrolate bromide MDI.
The company says that it submitted an application to the EMA via the centralized procedure for its HFA 152a beclomethasone dipropionate / formoterol fumarate / glycopyrrolate bromide MDI (Trimbow) and that it submitted applications for its HFA 152a beclometasone dipropionate / formoterol fumarate MDI (Fostair) through the decentralized procedure with Germany as the Reference Member State.
Chiesi has expanded its manufacturing site in La Chaussée-Saint-Victor, France, to support its manufacture of LGWP MDIs, and Bespak recently announced that it would further increase manufacturing capacity for LGWP propellant MDIs at its Holmes Chapel, UK site to support Chiesi.
Chiesi Executive VP, Region Europe TOP 5 and Interim AIR Franchise, Andrea Bizzi commented, “Innovation in patient care and environmental responsibility are not a trade-off. Our next generation carbon minimal pMDIs provide the same level of care, while reducing emissions of up to 90% compared to the ones in use today and at the same level of dry powder inhalers. These submissions are another step on our progression towards a full extrafine CMI portfolio across pMDIs and DPIs.”
Senior Director, Global Project Leader AIR Franchise Sara Panigone said, “The transition to carbon minimal pMDIs is not only a critical step in reducing the environmental impact of respiratory care but also helps to guarantee the long-term availability of a full range of effective inhaled medicines, protecting patient lives, ensuring access and continuity of care.”
Read the Chiesi press release
