AstraZeneca says top-line results from a post-marketing study show that Tudorza Pressair is effective in reducing chronic obstructive pulmonary disease (COPD) exacerbations in patients with cardiovascular issues.
According to data from the Phase IV ASCENT trial, there was a significant reduction in the annual rate of COPD exacerbations when the long-acting muscarinic antagonist Tudorza Pressair (aclidinium bromide) was added to background therapy in patients with moderate to very severe COPD, with a history of cardiovascular disease and/or significant cardiovascular risk factors.
Tudorza also met the primary safety endpoint, showing a time to first major adverse cardiovascular event (MACE) that was comparable to placebo, AZ noted.
ASCENT is a post-marketing requirement (PMR) trial requested by the US Food and Drug Administration (FDA) to investigate MACE in patients treated with aclidinium bromide – which is also marketed as Eklira and Bretaris and forms part of Duaklir (aclidinium bromide/formoterol fumarate) for up to three years.
A full analysis of the data is ongoing, and full results will be provided to the US FDA and presented at a forthcoming medical meeting.
AZ said it also plans to submit an application to expand Tudorza’s uses to include the treatment of COPD patients with CV risk factors.
“Cardiovascular disease is the most common comorbidity for patients living with COPD,” said Kenneth Chapman, Professor of Medicine in the Faculty of Medicine University of Toronto. “It is therefore very encouraging to see that aclidinium is effective in reducing exacerbation rates with no increase in cardiovascular events in this at-risk patient population.”
AZ and Circassia Pharmaceuticals are working together on the development and commercialisation of Tudorza and Duaklir in the US.