Circassia announced today that Duaklir® successfully completed a Phase III Study in Chronic Obstructive Pulmonary Disease (COPD) by demonstrating statistically significant and clinically meaningfully improvements in lung function. Following the completion of this study, AstraZeneca will file a New Drug Application (NDA) for Duaklir® with the United States Food and Drug Administration (FDA) during the first half of 2018.
Under the terms of the April 2017 collaboration established between Circassia and AstraZeneca, Circassia has exclusive commercialisation rights to Duaklir® in the United States and AstraZeneca is responsible for conducting the product's development. Circassia has exclusive commercialisation rights to Duaklir® in the United States.
Steve Harris, Circassia's Chief Executive, said:
"We are delighted with these positive phase III results and believe Duaklir® has the potential to provide a valuable treatment option for COPD patients in the United States. With treatment guidelines now placing a greater emphasis on LAMA/LABA combinations, we look forward to our partner AstraZeneca filing an NDA for Duaklir® in the coming months."