Posted by Michael Wonder on 01 Oct 2019
AstraZeneca provides an update on US regulatory review of PT010 in COPD
1 October 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new drug application for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease.
The application submitted to the FDA by AstraZeneca included data from the Phase III trial KRONOS.
The Company will now work closely with the FDA regarding next steps, including submitting for review recent results from the second positive Phase III trial, ETHOS, which was not completed at the time the NDA was submitted.
