MHRA Approves First Pressurised Metered-Dose Inhalers Containing a Next-Generation, Low GWP Propellant – Chiesi
Chiesi announces MHRA approval in the UK of Clenil Modulite (beclometasone; 100 mcg and 200 mcg) formulated with a next-generation, non-PFAS, low GWP propellant. These are the first pMDIs to use this propellant worldwide, with the UK being the first country to approve these products.
pMDIs remain the most widely prescribed inhaler device in the UK, accounting for around 70% of the 60 million devices prescribed each year.1,3 Chiesi’s propellant transition is expected to cut the carbon footprint of their beclometasone products by up to 90% versus that of the current propellant and aims to ensure continuity of care for patients by preserving device choice while addressing the environmental impact of these pMDIs.4
Professor Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine, University of Manchester – “this milestone represents a significant step forward in sustainable respiratory care. Studies have demonstrated the therapeutic equivalence and tolerability of beclometasone formulated with HFA-152a, versus the existing propellant, HFA-134a, so patients can maintain access to the treatment that works for them while the carbon footprint of these pMDIs is addressed in the background.”
The MHRA approval was informed by pharmacokinetic and safety studies which demonstrated therapeutic equivalence and tolerability between products formulated with HFA-152a, versus those formulated with HFA-134a. Orbia Fluor & Energy Materials, whose UK operation is based in Runcorn, is the manufacturing partner for the low GWP propellant used in these products.
Ralph Blom, General Manager, Chiesi UK and Ireland said, “Beclometasone (100 mcg and 200 mcg) are the first in Chiesi’s pMDI portfolio to transition to a low-GWP propellant – a significant milestone as we evolve our respiratory portfolio and advance towards our Net Zero by 2035 goal. Our focus is on delivering innovation that supports both patients and the planet, reducing environmental impact and supporting NHS decarbonisation goals, while preserving choice, access and flexibility in treatment.”
