Tudorza reduces exacerbations in COPD patients
AstraZeneca has announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair in patients with moderate to very severe COPD…
AstraZeneca has announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
When added to background therapy, Tudorza met the primary efficacy endpoint, demonstrating a statistically significant reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo. Tudorza also met the primary safety endpoint, demonstrating time to first major adverse cardiovascular event (MACE) comparable to placebo. In the trial, patients were randomised to receive Tudorza or placebo.
Steve Lewington, Global Medicine Leader, Respiratory, AstraZeneca, said: “The ASCENT data demonstrate that Tudorza, when added to background therapy, reduces exacerbation rates in patients with cardiovascular disease or risk factors and adds to the established efficacy and safety profile of aclidinium bromide. Based on these results, AstraZeneca plans to submit an sNDA for an expanded label for Tudorza in the US.”
Dr Kenneth Chapman, Professor of Medicine in the Faculty of the Medicine University of Toronto, said: “Cardiovascular disease is the most common comorbidity for patients living with COPD. 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.”
ASCENT is a post-marketing requirement (PMR) trial requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide. The trial included more than 3,600 patients from Canada and the US. The safety and tolerability profile of Tudorza was consistent with its label.
A full analysis of the data is ongoing. Full results will be provided to the US FDA and presented at a forthcoming medical meeting. AstraZeneca plans to submit an sNDA for an expanded Tudorza label.
In April 2017, AstraZeneca entered a strategic collaboration with Circassia Pharmaceuticals for the development and commercialisation of Tudorza and Duaklir (aclidinium bromide/formoterol) in the US.
Tudorza (aclidinium bromide) is a LAMA delivered through the Pressair DPI. Tudorza was approved in the US in 2012 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. Aclidinium bromide was approved in Europe in 2012 for the maintenance treatment of COPD.
Globally, it is now available to patients in more than 50 countries under the Tudorza, Eklira and Bretaris brand names. Aclidinium bromide is the LAMA in Duaklir (aclidinium bromide/formoterol fumarate), which is approved in more than 30 countries and under development for the US and China.