Chiesi says that it is on track with planned regulatory submissions in the EU for its ICS/LAMA/LABA MDI for the treatment of COPD by the end of 2016 after successful completion of two 12-month Phase 3 studies. According to the company, preliminary results from the studies of the extrafine beclamethasone/formoterol/glycopyrronium combination therapy in more than 4,000 patients demonstrated a greater than 20% reduction in yearly exacerbation rate and improved lung function vs LAMA and ICS/LABA therapies.
Principal Investigator Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine at Manchester University, said, “This is the first time that we have seen an effect of triple therapy on exacerbations. These studies show a consistent effect of the extrafine fixed triple therapy combination on a range of outcomes including exacerbations, lung function and quality of life. We can now properly see the substantial benefits that stepping up COPD patients to triple therapy can achieve”
Chiesi VP and Head of R&D Paolo Chiesi commented, “The superior efficacy in improving lung function, symptoms and quality of life, and in reducing COPD exacerbations, as compared to monotherapy or a fixed double combination therapy, shows that the extrafine fixed triple combination developed by Chiesi represents a substantial step forward in the therapy of COPD patients. Moreover, it is expected that the use of a single inhaler will lead to a greater adherence to treatment.”
Read the Chiesi press release.
