Circassia Pharmaceuticals showed positive clinical data from two studies of Tudorza and Duaklir, nearing the a deal with AstraZeneca in the United States.
ASCENT met its primary endpoints, showing that Tudorza is effective at reducing exacerbations with no increase in cardiovascular events in patients with moderate to very severe COPD and cardiovascular disease. AMPLIFY evaluated the efficacy of Duaklir compared with the product’s individual components. Amplify was conducted in more than 1,500 COPD patients over 24 weeks, met its co-primary efficacy endpoints.
The company said that it will submit a New Drug Application (NDA) for marketing approval for Duaklir in the United States in the coming weeks. The NDA will include data from the AMPLIFY study, results from two previous Duaklir phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.
Steve Harris, Circassia’s CEO, said: “With both the ASCENT and AMPLIFY studies meeting their primary endpoints, the positive data presented at the American Thoracic Society conference are highly supportive for Tudorza and Duaklir. As a result, we look forward to regulatory filings in the coming weeks seeking US approval for Duaklir and an extension to Tudorza’s US prescribing information to include the ASCENT data.”