AstraZeneca PLC said its triple-combination therapy PT010 was approved in China for a group of lung diseases called chronic obstructive pulmonary disease, or COPD.
The medicine was approved as a maintenance therapy, which is meant to either complement the main treatment or be used as a follow-up. PT010 is a combination of inhaled corticosteroid budesonide, with long-acting muscarinic agonist glycopyrronium and long-acting beta2-agonist formoterol fumarate, delivered through a pressurized metered-dose inhaler.
The U.K.-based pharmaceutical giant said the approval by China's National Medical Products Administration follows a priority review by the regulator. The approval was backed by data from a phase 3 trial, dubbed Kronos, which showed that the therapy significantly improved lung function in patients with COPD.
The therapy, marketed as Breztri Aerosphere in Japan, was rejected by the U.S. Food and Drug Administration in October.