Chiesi Group has announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company’s MAA for Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI. Chiesi has applied to market the extrafine formulation triple combination ICS/LABA/LAMA for the treatment of COPD.
The Trimbow submission is based on 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. Chiesi submitted the MAA for the product in September 2016; a final decision is expected in the 3rd quarter of 2017.
Chiesi Group VP and Head of R&D Paolo Chiesi commented, “Today’s positive opinion is an important step forward to make our extrafine triple combination available to COPD patients. COPD affects millions of people across Europe, and Chiesi is committed to developing new therapeutic options that could help these patients’ adherence to the therapy, thus reducing the risk of exacerbations and improving their quality of life. With this goal in mind, Chiesi has also developed the first fixed dose ICS/LABA/LAMA triple combination.”
Read the Chiesi press release.
