StockMarketWire.com - AstraZeneca said its lung disease drug had been approved in Japan as dual and triple combination therapies to be used in a pressurised metered-dose inhaler to relieve symptoms in patients with chronic obstructive pulmonary disease. The approval of approval of the company's lung disease drug Bevespi Aerospherea as a fixed-dose, long-acting dual bronchodilator was based on positive results from the Phase III Pinnacle 4 trial, as well as the broader Pinnacle clinical programme involving more than 5,000 patients, the company 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,' said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.

The approval of Bevespi Aerospherea as triple-combination therapy was based on positive results from the Phase III Kronos trial in which the drug demonstrated a 'statistically-significant improvement in trough forced expiratory volume in one second (FEV1), the primary endpoint for Japan, compared with the dual comparators,' it added.

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 pressurised metered-dose inhaler. 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, said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.



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