First approval of a fixed-dose, long-acting dual bronchodilator in a pressurised metered-dose inhaler device in Japan
AstraZeneca today announced that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).
This is the first approval by the Japanese Ministry of Health, Labour and Welfare for a maintenance fixed-dose, long-acting dual bronchodilator in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology.
The approval was based on positive results from the Phase III PINNACLE 4 trial,1 which demonstrated the efficacy and safety of Bevespi Aerosphere in 1,756 patients with moderate to very severe COPD across Asia, Europe and the US, as well as the broader PINNACLE clinical programme involving more than 5,000 patients.2,3,4
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “As the first medicine in its class to be approved in a pressurised metered-dose inhaler in Japan, Bevespi Aerosphere offers an important new treatment option and choice of inhaler device for patients with moderate to very severe chronic obstructive pulmonary disease.”
Bevespi Aerosphere is already approved in the US, EU, Canada, Australia and other countries as a dual bronchodilator for the maintenance treatment of moderate to very severe COPD.