23rd Dec 2019 08:12
(Alliance News) - AstraZeneca PLC said Monday its budesonide-glycopyrronium-formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease.
The drugmaker said this is the first approval by the National Medical Products Administration for a triple-combination therapy in a pressurised metered-dose inhaler, which uses Aerosphere delivery technology.
The approval follows a priority review and is based on results from the Phase III KRONOS trial, in which the triple-combination therapy demonstrated a statistically significant improvement in trough forced expiratory volume in one second, compared with dual-combination therapies.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: "Chronic obstructive pulmonary disease affects almost 100 million people in China, and is a leading cause of morbidity and mortality."
"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," Pangalos said.
AstraZeneca shares were down 0.1% in London at 7,804.00 pence each on Monday morning.
Late Friday, AstraZeneca and partner Daiichi Sankyo Co Ltd had said the US Food & Drug Administration has approved their drug Enhertu for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
By Loreta Juodagalvyte; [email protected]
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