Both Chiesi and the UK’s Medicines and Healthcare products Regulatory Agency have announced the MHRA’s approval of a reformulated Clenil Modulite beclometasone MDI for the treatment of asthma, marking the first approval of an MDI using Orbia‘s HFA 152a as a propellant. The newly approved 100 mcg and 200 mcg doses versions of the MDI are expected to be launched in the UK later this year.
The approval is not the first LGWP propellant approval for the MHRA, which previously approved a reformulation of AstraZeneca’s Trixeo Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI with HFO-1234ze.
In December 2019, Chiesi announced plans to launch an HFA 152a inhaler by the end of 2025. Earlier this year, Chiesi and CDMO Bespak announced an increase in manufacturing capacity for LGWP propellant MDIs at Bespak’s Holmes Chapel, UK site to support Chiesi products. 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 MDI.
MHRA Executive Director of Healthcare Quality and Access Julian Beach said, “This approval marks the world’s first authorisation of an inhaler using the next-generation propellant HFA-152a. It demonstrates how innovation can support both patient care and environmental sustainability while maintaining the high standards of quality, safety and effectiveness patients expect.”
Chiesi UK and Ireland General Manager Ralph Blom commented, “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 decarbonization goals, while preserving choice, access, and flexibility in treatment.”
Read the MHRA press release
Read the Chiesi press release
