This announcement contains inside information
01 October 2019 07:00 BST
Update on US regulatory review of PT010 in COPD
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).
The NDA submitted to the FDA by AstraZeneca included data from the Phase III trial KRONOS. The Company will now work