According to AstraZeneca, the FDA has issued a complete response letter to the company’s NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD.
AstraZeneca recently announced positive results from the Phase 3 ETHOS trial of PT010 and said that the MDI had been approved in Japan as Breztri Aerosphere. Results from the ETHOS trial were not included in the submission to the FDA, which did include data from the Phase 3 KRONOS trial. In January 2018, AstraZeneca said that the KRONOS trial had met 6 out of 7 lung function primary endpoints.
According to AstraZeneca, the Chinese National Medical Products Administration has granted priority review to PT010, and an MAA for the inhaler is currently under review in the EU.
Read the AstraZeneca press release.
