This combo treatment is known as PT010 outside of China, and as Breztri Aerosphere in Japan. It uses AstraZeneca’s Aerosphere Delivery Technology, a delivery system based on a special aerosol formulation (inhalation aerosol).
“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 pressurised metered-dose inhaler, an important device option for clinicians and patients in China,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in a press release.
According to Pangalos, COPD “affects almost 100 million people in China, and is a leading cause of morbidity and mortality.”
The new approval was based on the results of a Phase 3 clinical trial called KRONOS (NCT02497001), which compared the triple combo with the dual-combination therapies PT009 — containing formoterol fumarate and budesonide — and Bevespi Aerosphere, which contains formoterol fumarate and glycopyrronium. Patients participating in the 24-week KRONOS trial had moderate-to-very-severe COPD.
The results showed that patients with COPD who received the triple combo had improved respiratory function and a 52% reduction in the frequency of moderate or severe exacerbations compared with patients receiving only the dual-combination therapies. Respiratory function was measured by forced expiratory volume in one second (FEV1), which is the amount of air a person can forcefully exhale in one second.
The safety profile of the triple combo was found to be consistent with the known profiles of the dual-combination therapies analyzed.
“Addressing the burden of chronic obstructive pulmonary disease in China is a public health priority and triple-combination therapy will play an important role in helping patients manage their disease. In the KRONOS trial, budesonide/glycopyrronium/formoterol fumarate provided rapid and sustained lung function improvements in patients with moderate-to-very-severe disease,” said Wang Chen, director of the China National Clinical Research Centre for Respiratory Diseases, director of the Centre for Respiratory Disease at China-Japan Friendship Hospital, and China national lead investigator of the KRONOS trial.
The triple combo was approved in Japan in June 2019 as Breztri Aerosphere, and is under regulatory review in the U.S. and the European Union.