This makes Japan the first country to grant regulatory approval for Breztri Aerosphere.
Breztri Aerosphere, which is composed of budesonide, glycopyrronium and formoterol fumarate, is also the first triple combination therapy contained in a pressurized metered-dose inhaler to be granted approval by the Japanese Ministry of Health, Labour and Welfare.
“Chronic obstructive pulmonary disease affects more than five million people in Japan, and Breztri Aerosphere offers these patients a new, powerful triple-combination therapy in a pressurized metered-dose inhaler,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a press release.
“This first approval of Breztri Aerosphere is a significant step towards providing a new treatment choice to people living with chronic obstructive pulmonary disease globally,” he added.
Approval was based on positive results from the Phase 3 KRONOS trial (NCT02497001) which showed that Breztri Aerosphere could lead to significant improvement in COPD patients’ respiratory function — determined by changes in forced expiratory volume in one second (FEV1) — in comparison with the company’s dual combination therapies Bevespi Aerosphere (composed of glycopyrronium/formoterol fumarate) and PT009 (composed of budesonide/formoterol fumarate).
Treatment with Breztri Aerosphere also led to a significant 52% decrease in the rate of moderate or severe COPD exacerbations (acute worsening events) compared with approved therapy Bevespi Aerosphere.
“The KRONOS trial demonstrated that Breztri Aerosphere provides rapid and sustained, clinically-relevant lung function improvements in patients with moderate to very severe chronic obstructive pulmonary disease,” said Klaus Rabe, professor of pulmonary medicine at the University of Kiel in Germany and national coordinating investigator of the KRONOS trial. “Triple-combination therapy is an increasingly important treatment option and will play a central role in helping patients manage their disease.”
Results from the KRONOS trial were published last year in the article, “Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial,” in the journal The Lancet Respiratory Medicine.
The Chinese National Medical Products Administration has granted priority review to Breztri Aerosphere. A final decision is expected to be announced in the second half of this year.
Breztri Aerosphere is also under review in the United States and European Union, with regulatory decisions expected in 2020.