Phase IV post-marketing study of Tudorza found the treatment significantly reduced exacerbations of chronic obstructive pulmonary disease, Circassia Pharmaceuticals said.
Conducted by Circassia’s partner AstraZeneca, the ASCENT study was conducted in over 3,600 patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The study met its primary efficacy endpoint, with Tudorza demonstrating statistically significant reductions in the rate of moderate or severe COPD exacerbations compared with placebo.
In addition, Tudorza met its primary safety endpoint, demonstrating a favourable cardiovascular safety profile, with the time to patients experiencing a first major adverse cardiovascular event similar to placebo.
Cardiovascular disease is the most common and significant comorbidity of COPD.
Under the April 2017 collaboration established between Circassia and AZ, Circassia has responsibility for marketing Tudorza in the US, and AZ is responsible for conducting the product’s clinical studies.
Following the successful completion of the study, AZ plans to file a supplemental New Drug Application (sNDA) with the US FDA to request inclusion of the trial data in Tudorza’s label.
“We are highly encouraged with the progress we are making in our US commercial collaboration with AstraZeneca, and look forward to our partner filing for an extension to Tudorza’s label in the coming months,” said Circassia Chief Exec Steve Harris.