AstraZeneca has announced that its PT010 budesonide/glycopyrronium/formoterol fumarate MDI has been approved by the Chinese National Medical Products Administration for the treatment of COPD. PT010 was approved in Japan as Breztri Aerosphere in June 2019.
According to AstraZeneca, the approval was based on results from the Phase 3 KRONOS trial, which had a primary endpoint for China of improvement in FEV1 compared to Bevespi Aerosphere glycopyrronium/formoterol fumarate and PT009 budesonide/formoterol fumarate.
In January 2018, AstraZeneca announced that the KRONOS trial met 6 out of 7 primary endpoints. Data from that trial were included in an NDA for PT010 that was submitted to the FDA; AstraZeneca said in October 2019 that the FDA had issued a complete response letter to that application.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “Chronic obstructive pulmonary disease affects almost 100 million people in China, and is a leading cause of morbidity and mortality. With this approval, we are now able to provide a powerful new triple-combination therapy to patients for whom new treatments are critically needed. Our triple-combination therapy is administered in a pressurized metered-dose inhaler, an important device option for clinicians and patients in China.”
Read the AstraZeneca press release.
