According to Chiesi, the FDA has accepted the company’s NDA for its CHF5993 beclomethasone dipropionate /formoterol fumarate / glycopyrrolate MDI for the treatment of asthma. In April 2024, Chiesi announced that it was initiating a Phase 3 trial of an HFA 152a version of the inhaler. The new announcement says that the application is supported by data from the Phase 3 TRIGGER and TRIMARAN studies of the HFA 134a triple combination inhaler in asthma patients.
In Europe, where it is marketed as “Trimbow,” the MDI has been approved for the treatment of COPD in certain patients since 2017 and for the treatment of asthma in certain patients since 2021. Trimbow MDI is also marketed in the UK and China, the company says.
Chiesi VP of US Medical Affairs Martin Marciniak commented, “The FDA’s acceptance of Chiesi’s New Drug Application for our fixed-dose triple combination inhaler represents another important step in our journey to delivering solutions that address respiratory needs and reduce the burden that persists for people living with asthma, their caregivers, and the healthcare system in the US . . . .we have created medicines in this area for more than four decades, and transformed respiratory care by creating and commercializing the first triple therapy for asthma outside the US.”
Read the Chiesi press release
