The European Commission has approved Chiesi’s Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI for the treatment of COPD in patients for whom an ICS/LABA combination is insufficient to control symptoms and prevent exacerbations, the company said.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the MAA for Trimbow in May 2017.
Chiesi Group Region Europe Head Alessandro Chiesi said, “The marketing authorization of Trimbow in the EU is a significant treatment advance for COPD patients and reinforces the Chiesi Group’s leadership in the respiratory arena. Trimbow is the first approved fixed triple combination therapy in a single inhaler for the treatment of COPD. The use of one inhaler should simplify the intake of the therapy and therefore may improve adherence. We aim to make this treatment available to patients in Europe as soon as possible.”
Chiesi submitted the MAA for the product in September 2016. The application was supported by data from two 12-month Phase 3 studies that showed superior effectiveness of the triple combination compared to an ICS/LABA combination and compared to a LAMA.
Read the Chiesi press release.