Triple-combo inhaler for COPD in JapanAugust 6, 2019
AstraZeneca announced that Breztri Aerosphere (budesonide/ glycopyrronium/ formoterol fumarate) has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD).
This is the first global regulatory approval for Breztri Aerosphere and is the first approval by the Japanese Ministry of Health, Labour and Welfare for a triple-combination therapy in a pressurised metered-dose inhaler (pMDI).
The approval was based on positive results from the phase III KRONOS trial in which Breztri Aerosphere demonstrated a statistically significant improvement in trough forced expiratory volume in one second (FEV1), the primary endpoint for Japan, compared with the dual comparators Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).
The Chinese National Medical Products Administration has granted a priority review to Breztri Aerosphere, with an expected regulatory decision in the second half of 2019. The medicine is also under regulatory review in the US and EU with anticipated regulatory decisions in 2020.